Quality Assurance Compliance Specialist
Piramal Pharma Ltd•Bethlehem, PA
4d•Onsite
About The Position
Support GMP activities within the Bethlehem plant with an emphasis on reviewing records and lab reports for the release of drug product. Also responsible for contributing to maintaining Documentation activities and Documentation Control coverage, assisting with QC testing reviews and monitoring of manufacturing and packaging processes. Responsible for various day to day activities in the Quality Assurance areas. This is a 2nd shift position
Requirements
- Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
- Excellent verbal and written communication skills
- Creative and able to present various solutions
- Energetic, enthusiastic and motivational disposition
- Maintain confidentiality
- Coaching skills
Responsibilities
- Packaging Batch Records: Reviews final batch records on paper and electronically, documents batch errors from various departments, tracks, and issues reports.
- Manufacturing Batch Records: issues batch records to production, electronically review production batch records, file and archive all the completed physical records.
- Review lab data on paper/electronically for inclusion on C of A
- Responsible for certificate of acceptance (C of A) generation for Bulk and Finished drug product, coordination of finished batch status tracking
- Releases product within SAP and generates reports as needed
- Reviews calibration sheets.
- Supports the quality document archive system
- Assist in the activities related to document control when needed
- Act as a backup to other QA associates in his/her absence
- Performs and supports internal audits and regulatory agency audits as needed
- Performs special projects as directed by Quality Assurance management
- Trains new employees in the department on the various tasks
- Supports launch of new products in auditing/ understanding new processes as needed
- Assist with reviews and investigations for Deviations
- Assist with and/or conduct APRs
- Assist with and/or conduct the updating of CRNs
- Produce logbooks as requested
- Supports RA requests relative to filings and submissions
- Support Packaging Line Inspector including coverage as needed
- Assist with and/or conduct BOM and MBR updates
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
