Quality Specialist - II (Associate) Quality Specialist - II (Associate)
Salary undisclosed
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Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required.
The Specialist must demonstrate strong leadership capability, critical thinking skills, and the ability to work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands.
This position is knowledgeable in regulatory requirements and ensures site compliance with all expectations.
Education: Must possess a B.A. /B.S. degree (preferably in Science or Engineering).
Required Experience And Skills
" Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.
" Must possess a minimum of minimum of three (3) years experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
" Must possess highly developed written and oral communication and teamwork skills.
" Additionally must have strong attention to detail, problem solving skills, and proficient in time management.
" Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.
" Flexible, Multitasker, able to work under pressure and adheres to project timelines.
" Ability to independently respond to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards And Accolades
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required.
The Specialist must demonstrate strong leadership capability, critical thinking skills, and the ability to work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands.
This position is knowledgeable in regulatory requirements and ensures site compliance with all expectations.
- **Retrieval and tracking of site Batch Records including, but not limited to, retrieval from Operations, archiving into the appropriate tracking system, scanning for Canadian market, and filing in applicable Document Retention room.
- **Tracking, retrieval, storage (including shipping offsite), execution of retrieval challenges, and destruction of batch records beyond retention period as applicable.
- **Ensure proper allocation of Document Retention room capacity.
- **Assist with the reconciliation of High/Medium controlled print documents.
- **Retrieve, prepare, and provide Certificate of Compliance (CoC) for the finished goods batches as requested. Additionally, support retrieval, preparation, and submission of requested Certificate of Analysis (CoA) for associated bulk drug product batches associated with the requested finished goods batches.
- **Support the tracking and processing of Registered Country Table (RCT) tender request forms regarding allocation of material / batches within SAP system for markets beyond the designated marketing location.
- **Batch record review and intermediate/finished product release activities for domestic distribution.
- **Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations.
- **Defect resolution, including use of statistical methods, and control of material throughout the plant site.
- **Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition.
- **Ownership and completion of Quality related investigations.
- **Participates in project and PCR strategy meetings in support of Quality Master Data builds and maintenance
- **Participates in the implementation of new programs/regulations/divisional processes at the site.
- **Identifies continuous improvement (business and compliance excellence) opportunities and through collaboration and engagement with other functional groups, implements changes to processes.
- **Maintains 5S organization and identifies improvement opportunities.
- **Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
Education: Must possess a B.A. /B.S. degree (preferably in Science or Engineering).
Required Experience And Skills
" Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.
" Must possess a minimum of minimum of three (3) years experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
" Must possess highly developed written and oral communication and teamwork skills.
" Additionally must have strong attention to detail, problem solving skills, and proficient in time management.
" Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.
" Flexible, Multitasker, able to work under pressure and adheres to project timelines.
" Ability to independently respond to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards And Accolades
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required.
The Specialist must demonstrate strong leadership capability, critical thinking skills, and the ability to work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands.
This position is knowledgeable in regulatory requirements and ensures site compliance with all expectations.
Education: Must possess a B.A. /B.S. degree (preferably in Science or Engineering).
Required Experience And Skills
" Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.
" Must possess a minimum of minimum of three (3) years experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
" Must possess highly developed written and oral communication and teamwork skills.
" Additionally must have strong attention to detail, problem solving skills, and proficient in time management.
" Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.
" Flexible, Multitasker, able to work under pressure and adheres to project timelines.
" Ability to independently respond to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards And Accolades
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required.
The Specialist must demonstrate strong leadership capability, critical thinking skills, and the ability to work independently to ensure job responsibilities are conducted in a timely and reliable manner to meet production demands.
This position is knowledgeable in regulatory requirements and ensures site compliance with all expectations.
- **Retrieval and tracking of site Batch Records including, but not limited to, retrieval from Operations, archiving into the appropriate tracking system, scanning for Canadian market, and filing in applicable Document Retention room.
- **Tracking, retrieval, storage (including shipping offsite), execution of retrieval challenges, and destruction of batch records beyond retention period as applicable.
- **Ensure proper allocation of Document Retention room capacity.
- **Assist with the reconciliation of High/Medium controlled print documents.
- **Retrieve, prepare, and provide Certificate of Compliance (CoC) for the finished goods batches as requested. Additionally, support retrieval, preparation, and submission of requested Certificate of Analysis (CoA) for associated bulk drug product batches associated with the requested finished goods batches.
- **Support the tracking and processing of Registered Country Table (RCT) tender request forms regarding allocation of material / batches within SAP system for markets beyond the designated marketing location.
- **Batch record review and intermediate/finished product release activities for domestic distribution.
- **Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations.
- **Defect resolution, including use of statistical methods, and control of material throughout the plant site.
- **Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition.
- **Ownership and completion of Quality related investigations.
- **Participates in project and PCR strategy meetings in support of Quality Master Data builds and maintenance
- **Participates in the implementation of new programs/regulations/divisional processes at the site.
- **Identifies continuous improvement (business and compliance excellence) opportunities and through collaboration and engagement with other functional groups, implements changes to processes.
- **Maintains 5S organization and identifies improvement opportunities.
- **Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
Education: Must possess a B.A. /B.S. degree (preferably in Science or Engineering).
Required Experience And Skills
" Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.
" Must possess a minimum of minimum of three (3) years experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
" Must possess highly developed written and oral communication and teamwork skills.
" Additionally must have strong attention to detail, problem solving skills, and proficient in time management.
" Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.
" Flexible, Multitasker, able to work under pressure and adheres to project timelines.
" Ability to independently respond to advances requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards And Accolades
" America's Most Honored Businesses (Top 10%)
" Awarded by USPAAC for Fastest Growing Business in the US
" 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
" Fastest 50 by NJ Biz (2020, 2019, 2020)
" INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
" Top 100 by Dallas Business Journal (2020 and 2019)
" Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
" 2019 Spirit of Alliance Award by Agile1
" 2018 Best of the Best Platinum Award by Agile1
" 2018 TechServe Alliance Excellence Awards Winner
" 2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email: