Sr. QC Specialist

Essential Responsibilities

· Help Develop, implement and maintain QC systems and measures.

· Inspect and test Raw Materials, Fragrances, In-Process and Customer supplied bulk, against specification to ensure quality standards are met.

· Issue adjustments to In-Process Bulk if necessary.

· Complete Inspections forms for Finished Bulk/Intermediate and /or Raw Materials and Fragrances.

· Update status of Raw Materials and /or Bulk/Intermediate in ERP system.

· Communicate quality control information to all relevant organizational departments.

· Produce and communicate reports regarding nonconformance of products.

· Assist in investigations related to Nonconformance or OOS, Customer Complaint etc.

· Maintain the raw material retains for the Department.

· Assist in updating or writing Department related SOPs and Work Instructions or other Department related documents.

· Assist in Raw Materials and Bulk /Intermediate Cycle Counts and Full Inventories

· Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff and vendors and outside agencies.

· Complete all other additional tasks assigned by supervisor.

· Adhere to company policies and procedures and sets a positive example for others within the organization.

Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Discretion in handling confidential and sensitive matters.

· Knowledge of drug cGMPs, SOPs and regulatory guidelines including FDA requirements.

Education, Experience

· Bachelor’s degree in science (chemistry, pharmacy, or biology) or equivalent work experience.

· 2+ years Quality Control related experience in a cGMP OTC manufacturing environment.

Technical Skills

· Proficient use of Microsoft Office products including Word, Excel, Outlook and PowerPoint.

· Ability to quickly learn new software programs as needed.

· Experience using common laboratory equipment such as pH Meter; Refractive Index; Pycnometer; Brookfield Viscometer; Color Matching; Scales; and lab mixers

Mathematical Skills

· Must be able to analyze and present quantitative data.

· Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication and percentages.

Reasoning Ability

Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise including:

· Resolve issues of a general, routine and complex nature and exercise appropriate judgment to escalate issues to senior management.

· Effectively prioritize routine and non-routine work assignments to ensure goals and timelines are met.

· Apply knowledge of Quality Control best practices, cGMPs, regulations, and Company policies to problems and provide appropriate resolution.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

· Must have good visual/organoleptic alertness.

· Work will be conducted in a standard office and manufacturing environment with associated distractions such as noise from telephones, keyboards, talking, paging systems, production equipment and warehouse activities. Temperatures are regulated by facilities management and are not within the direct control of the individual.

· Most work is done while sitting down, using a computer keyboard and gazing at a computer monitor.

· Position requires the incumbent to move from the work area to other areas of the company, including other offices, cubicles, warehouse and production areas, conference rooms and other offices in the same building or another building. The incumbent may be required to walk or drive his or her own vehicle to a second location a short distance away.

· Must be able to sit for up to eight hours per day, lift and carry up to 20 lbs with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor level cabinet or drawer; push and pull, use a computer keyboard throughout the workday, stand while filing or performing other essential responsibilities.

· Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or white out. Additionally, the incumbent will be exposed to chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs.