Senior Specialist, Quality Assurance
Location: West Point, PA
Overview
If you want to make a world of difference, we want you. As a Senior Specialist, Quality Assurance, you'll head up the maintenance of the clinical supply chain for sterile dosage drug product manufacturing, and you'll oversee GMP quality assurance procedures in both internal and external solid dosage production, as well as batch release for clinical trial supply.
Primary Responsibilities
- Management of quality assurance procedures during clinical development stage
- Quality review and approval of irregularity investigations; quality review and approval of batch production and completed dosage & alteration records
- Confirmation of adherence to relevant regulatory specifications (prior to batch release/rejection)
- Formation & maintenance of stakeholder relations
- Establishment & enforcement of SOPs under GMP guidelines
- Preparation for and participation in audits/inspections; administration of all needed corrective and preventative actions
Qualifications & Skills
- Bachelor's degree in Science, Engineering, Business, or similar discipline
- 2-3 years of experience in a role within the pharmaceutical or biotechnology (or other related) industries
- Intimate familiarity with cGMP
- Firsthand experience with GMP quality, operations, laboratories; experience at the interface between quality and internal or external manufacturing
- Strong written & verbal communication skills, collaborative spirit across functions, conflict resolution
- Proven project management skills
Preferred Experience
- Advanced degree or other certification in a managerial, technical, quality, or other regulatory discipline
- Sterile dosage manufacturing and analytical testing
- Background in quality assurance, operations, or related functional positions. Some examples include: quality assurance, process engineering, supply chain management, and CMC regulatory affairs
- Any experience in a GMP environment, including batch production record creation, the review/approval process, ancillary batch records, change control, cleaning, and validation protocols
- Demonstrated ability to identify and resolve problems in a punctual, efficient manner
- Working knowledge of R&D and clinical supply processes