- Location: Aurora, OH
- Type: Contract To Hire
- Job #36270
$24/hour – Monday to Friday 7a-3:30p – Contract to Hire
This global leader in biopharma manufacturing is seeking an experienced quality professional to join their expanding team. This is a great opportunity to work at a cutting-edge facility with state-of-the-art equipment and systems. The successful candidate will have industry experience working in a regulated environment and following GMPs and GDPs. This role is perfect for those who crave upward mobility and career development as this department is experiencing quick growth!
- Inspects shipments, reconciles labels, reviews and releases finished product and other paperwork.
- Reviews QC testing documentation and results for conformance.
- Confirms expiration dating and issues Certificates of Analysis for each lot.
- Reviews and approves/rejects other various quality-related documents.
- Assists in planning, developing, and implementing quality assurance programs.
- Responds to customer requests, including but not limited to investigating complaints and completing required paperwork for corrective and preventive actions and associated follow-up.
- Assists in changing and maintaining ISO and cGMP paperwork. Trains or oversees training.
- Ensures the quality requirements of all departments are followed and are accurately documented.
- Completes PM/Calibration documentation files and manages Out of Service Equipment
- Oversee to assure Validations are performed according to approved protocols and samples provided as requested.
- Interprets, understands, and manages a variety of technical information.
- Prepares routine, technical, and special presentations/reports to staff and management as required.
- Prepares and compiles statistical analysis of quality assurance data.
- Oversees the writing and maintenance of owner’s process manuals.
- Coordinate and perform quality assurance system internal audits, investigate non-conformances and determine root cause analyses.
- Reviews the current policies determining and documenting any areas that may need quality improvements.
- Perform other duties as assigned.
- Bachelor of Science in Microbiology, Chemistry, Biology, or related field
- 1-3 years of GMP and GDP experience in a regulated environment such as PNG, J&J, Dial, Unilever, etc. (required)
- SAP experience highly preferred!