This position is responsible for performing Quality Assurance (QA) oversight of GMP compounding activities at SCA Pharmaceuticals. This position performs the QA review of batch records for final products and intermediates, coordinates testing of samples with the QC department, and reviews and evaluates QC data to ensure that lots meet applicable cGMP requirements prior to release. This position is responsible for the generation and issuance of plant documentation including: Standard Operating Procedures (SOP’s), Trainings, and Change Controls at SCA Pharmaceuticals.
BE ADVISED THE POSITION HOURS ARE AS FOLLOWS: 9AM - 6PM
- Review executed compounding batch records, and associated documentation for compliance with cGMPs and consistency with other SCA policies and procedures.
- Coordinate lot release schedule with Operations and Warehouse management to ensure efficient and on time release of product batches.
- Coordinates with QC for the testing of samples from compounding.
- Review and evaluate QC data for release and approval of batch records and drug product.
- Record Quality data metrics including batch record receipt and review information as well as release information. .
- Assists in the development of SCA SOPs, Batch Records and review checklists for compliance with cGMPs and consistency with other SCA policies and procedures.
- Provides batch related updates to the SCA management team in regards to pending releases and potential delays.
- Performs other duties as assigned.
Successful Candidates Will Have:
- Must have effective communication and interpersonal skills across all functions within the organization and outside.
- Strong organizational and record keeping skills are required.
- Strong working knowledge of Word, Excel, and PowerPoint is necessary.
- Requires the ability to check mathematical calculations.
- Minimum: High School diploma or equivalent GED.
- Preferred: Four-year college degree or equivalent Quality experience.
SCA Pharmaceuticals is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.