QA Specialist III
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.Role Summary
The QA Specialist is the primary contact for quality on the production floor. This role will monitor production processes for compliance to cGMP standards. QA Specialists must collect samples from designated locations on R1 Finishing Lines as required by SOP. He/She will perform and document the appropriate testing and inspection results in order to support product release.Role Responsibilities
- Must verify critical product labeling information such as lot and list number, expiration date, product description, and manufacturing date (if applicable).
- Must be certified by the training department to perform Modified Manual Inspection (MMI) techniques for the product types processed in the finishing areas. Must obtain a representative number of AQL samples from the production line for visual inspection. Based on the product requirements, the samples may also require physical and/or functional testing.
- Must obtain samples that are required for long term storage for stability testing and annual retention inspection.
- Must adhere to all safety and health practices and procedures.
- Candidate must be able to perform sampling calculations based on an hourly production output to determine the required number of samples to satisfy the lot size. Calculations are also required to determine the number of corrugate samples required per lot.
- Candidate must be able to act with ownership in their areas of responsibility and perform other related assignments and duties as required and assigned. Responsibilities include but not limited to the classification of defects, addressing entries on documents made with their signature, assisting validation inspections and/or retain inspection (if needed)
- Candidate should be able be proactive with preventing delays and/or downtime of equipment.
- Must have a high school diploma with a minimum of 1+ years of related experience in an FDA regulated industry (preferably in quality assurance or quality control) with knowledge to provide guidance on quality related concerns. A Bioworks Program certificate may be used in the place of the work experience.
- Must possess the basic knowledge of cGMPs and FDA requirements and computer skills.
- Must have excellent organizational, interpersonal and communication skills (oral and written).
- Must have a proven ability to work with minimum supervision.
- May require lifting up to 35 lbs, sitting, standing for periods of up to 90 minutes, walking, bending for extended periods of time, and performance of repetitive motions for up to 60 minutes.
- Must also be able to perform mathematical calculations and some data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some overtime work may be required. The position is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards. Travel for this position is minimal. Shift is 1st, 7am- 3pm (Monday-Friday).
Other Job Details:
- Last Date to Apply for Job: August 2nd 2021
- Eligible for Relocation Assistance: No
- Eligible for Employee Referral Bonus: YES