- 6-month contract to hire
- Pay rate range is $62.31-$66.44/hr.
- Fully onsite in Philadelphia, PA.
- Mon-Friday 8a-5p - some weekend coverage
- Quality Control Expertise: At least 5 years in the biopharmaceutical sector.
- Regulatory Proficiency: Solid experience with OOS investigations, deviations, change controls, and CAPAs.
- Educational Foundation: Bachelor's degree and 5+ years' experience, preferably with cell/gene therapy products.
- Investigative Analysis: Extensive QC/QA background in lab investigation reviews and change control documentation.
- Vendor Collaboration: Proven track record of managing external partnerships.
- Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events.
- Performs review and approval of CMO/CTL change controls.
- Performs data analysis of CMO release testing to support product lot release with adherence to turnaround times.
- Issue and write change controls and CAPAs when required.
- Analyze and interpret technical laboratory data. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the laboratory operations environment.
- Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate documents.
- Due to the nature of testing schedules, must be willing to work weekends, evenings, and holidays, as needed.
- All duties are performed with minimal supervision and oversight.
- Performs other duties as assigned.
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- Minimum 5 years of experience in the biopharmaceutical industry within a Quality Control role
- Must have experience with OOS investigations, deviations, change controls and CAPAs.
- Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
- Solid understanding and functional knowledge with hands-on experience with Cell base Assays, cell culture (primary cells and cell lines),
- Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)
- Extremely detail-oriented with strong analytical, written, and verbal communication skills
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but leads efforts to resolve them.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- Successfully interface with multi-disciplined teams
- High level of ownership and accountability.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
- Bachelor's degree with 5 years of relevant experience with cell therapy products is a plus.
Sr. Quality Control Specialist - Philadelphia, United States - Planet Pharma
Description
Top 5 Skills
Overview
The Senior Quality Control Specialist - External Operations is responsible for the review of the executed test methods and raw data for lot release. This role must have a good understanding of Quality Control and apply practical knowledge of phase appropriate GMPs and regulatory requirements in the product development life cycle, including but not limited to: Lot release; Method qualification and validation, Technology Transfers, and writing/review of QC procedures. Experience working in a GMP-regulated environment is essential, including knowledge of health authority expectations for novel and complex oncology programs. This position will require the candidate to be on-site at either their manufacturing CMO or their integrated Cell Therapy Center.
Essential Functions and Responsibilities
Required Education, Skills, and Knowledge
Preferred Education, Skills, and Knowledge