Senior QA Specialist
Senior QA Specialist
Our client, a leading pharmaceutical company focused on discovering, developing, manufacturing and commercializing small molecule drugs, is currently seeking a Sr. QA Specialist fora 6-month contract in the GMP Operational Quality group with the possibility to extend. This person will serve as in an internal expert in the principles and application of quality assurance and compliance, coordinating GMP activities in support of clinical and commercial drug product disposition.
- Providing quality oversight and support to operations in the following key areas/activities; manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management
- Product Release – Internal Manufacturing:
- Responsible for reviewing batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
- Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
- Responsible for archival of batch records and other supporting documents in QDoCCs
- Compliance Oversight of Internal Operations and Quality Systems
- Provide production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.
- Review and approval of Manufacturing documents (as required)
- Responsible for raw material release, area clearance, line clearance and equipment release
- Provide QA support of change controls, GMP investigations and CAPAs (as required).
- Responsible for updating QA database to support generating performance metrics, trends.
- Participate in compliance walkthroughs and help drive the closure of any observations
- Responsible for identifying risks and communicating gaps for GMP process/systems
- Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
- Participate in inspection readiness and support activities (as necessary)
- Participate in process improvement initiatives (as necessary).
- Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.
- Experience providing QA support and oversight of GMP manufacturing operation including batch release
- Experience with network-based applications such as Oracle, TrackWise, VeeQMS
- Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
- cGMP’s and associated CMC regulatory considerations
- experience with continuous manufacturing a plus
- Experience providing QA support and oversight of Material Management operations including incoming material release.
- Demonstrated success by independently coordinating with cross-functional teams
- Ability to perform functions independently in accordance with cGMP guidelines.
- Strong written and oral communication skills required
- Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
- Proven experience supporting GMP manufacturing either via experience in manufacturing and /or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role
- Experience with release of incoming materials and materials management
- Project management skills desirable
- Medical device experience a plus
- Must be authorized to work in the United States
If you are interested in this position, please send your resume to firstname.lastname@example.org