Senior Analyst, Quality Control - Cell Therapy, Raw Materials
Salary undisclosed
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Introduction to role:
Join us at AstraZeneca as a Quality Control Senior Analyst in our commercial cell therapy manufacturing facility. This role is pivotal in ensuring the quality, safety and compliance of incoming raw materials through chemical and physical analysis. If you have a strong background in GMP, quality control, good documentation practices and a proven track record of high quality, right first-time test execution, we want to hear from you!
Accountabilities:
As a Senior Analyst, you will facilitate technical transfer, qualification and validation of raw material QC methods. You will conduct routine testing and analysis of raw materials following compendial (e.g. USP. EP) and/or internal test methods and standard operating procedures to ensure compliance with regulatory standards. You will also be responsible for maintaining the QC laboratory and equipment in accordance with written procedures. Additionally, you will author, revise and review SOPs, protocols, reports, raw material specifications and other relevant documentation.
Essential Skills/Experience:
- A bachelor's or master's degree or equivalent in biological sciences, chemistry, biochemistry or related field.
- B.S. with 5+ years of experience or M.S. with 3+ years of experience
- Previous experience in technical method transfers, qualification and / or validation.
- Hands-on experience in executing analytical method techniques such as pH, FTIR/Raman, HPLC and wet chemistry compendial methods.
- Working knowledge on compendial requirements, e.g., USP, EP.
- Prior experience in a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for raw materials.
- Strong attention to detail and problem-solving skills.
- Excellent interpersonal, verbal and written communication skills.
- Ability to work collaboratively as part of a high performing team.
Preferred Skills/Experience:
- Prior experience performing/managing analytical testing of raw materials with short turn-around times.
- Experience with Labware Laboratory Information System (LIMS) and SAP
- Cell Therapy Experience
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
T h e annual base pay (or hourly rate of compensation) for this position ranges from $74,778 - $112,166. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
At AstraZeneca, we take Quality seriously. We are constantly innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We are strong communicators and networkers, working together as a team to get our pipeline out to patients sustainably, reliably and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca.
Are you ready to make a real-life difference to patients? Join us at AstraZeneca where we have built an unrivalled reputation in Quality, through our 'Total Quality' culture that takes us beyond pure compliance. Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Join us at AstraZeneca as a Quality Control Senior Analyst in our commercial cell therapy manufacturing facility. This role is pivotal in ensuring the quality, safety and compliance of incoming raw materials through chemical and physical analysis. If you have a strong background in GMP, quality control, good documentation practices and a proven track record of high quality, right first-time test execution, we want to hear from you!
Accountabilities:
As a Senior Analyst, you will facilitate technical transfer, qualification and validation of raw material QC methods. You will conduct routine testing and analysis of raw materials following compendial (e.g. USP. EP) and/or internal test methods and standard operating procedures to ensure compliance with regulatory standards. You will also be responsible for maintaining the QC laboratory and equipment in accordance with written procedures. Additionally, you will author, revise and review SOPs, protocols, reports, raw material specifications and other relevant documentation.
Essential Skills/Experience:
- A bachelor's or master's degree or equivalent in biological sciences, chemistry, biochemistry or related field.
- B.S. with 5+ years of experience or M.S. with 3+ years of experience
- Previous experience in technical method transfers, qualification and / or validation.
- Hands-on experience in executing analytical method techniques such as pH, FTIR/Raman, HPLC and wet chemistry compendial methods.
- Working knowledge on compendial requirements, e.g., USP, EP.
- Prior experience in a Quality Control or GMP testing laboratory and knowledge of cGMP and regulatory requirements for raw materials.
- Strong attention to detail and problem-solving skills.
- Excellent interpersonal, verbal and written communication skills.
- Ability to work collaboratively as part of a high performing team.
Preferred Skills/Experience:
- Prior experience performing/managing analytical testing of raw materials with short turn-around times.
- Experience with Labware Laboratory Information System (LIMS) and SAP
- Cell Therapy Experience
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
T h e annual base pay (or hourly rate of compensation) for this position ranges from $74,778 - $112,166. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
At AstraZeneca, we take Quality seriously. We are constantly innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We are strong communicators and networkers, working together as a team to get our pipeline out to patients sustainably, reliably and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca.
Are you ready to make a real-life difference to patients? Join us at AstraZeneca where we have built an unrivalled reputation in Quality, through our 'Total Quality' culture that takes us beyond pure compliance. Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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