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Recruitment Consultant - Life Science and Engineering at Berkley Group
Quality Assurance Specialist
We are seeking an experienced Quality Assurance Professional to provide quality direction and oversight for activities related to Technology Transfer, New Product Introductions (NPI), and Product Lifecycle Management (LCM). This role requires a strong focus on technical transfer processes, including QA leadership in preparation and execution of Process Performance Qualification (PPQ) and validation activities, within a pharmaceutical sterile manufacturing environment.
Responsibilities:
* Technical Transfer and NPI Oversight:
Provide overall quality direction for processes and procedures associated with technology transfer, NPI, and product lifecycle changes.
Act as the Quality point of contact and decision-maker during technology transfer and PPQ execution activities, ensuring all activities comply with regulatory and company standards.
* Validation and Documentation:
Quality review and approval of validation documentation, including:
Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
Ensure robust and compliant validation documentation to support site activities.
* Risk Management and Compliance:
Conduct risk assessments and develop mitigation strategies for potential challenges in process transfers.
Provide input and quality oversight for change control development and implementation.
Ensure timely and robust implementation of change controls and CAPA records.
* Process and Product Support:
Quality review and approval of Bill of Materials (BOMs), Master Batch Records (MBRs), and production recipes.
Collaborate with cross-functional teams to optimize processes and ensure successful scale-up and commercial manufacturing.
* Documentation and SOPs:
Write, review, and approve Standard Operating Procedures (SOPs) in alignment with Amgen policies.
* Regulatory and Safety Compliance:
Ensure all activities align with Amgen's safety standards, SOPs, and regulatory expectations.
Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Basic Qualifications:
* University degree in a Science or Engineering-related discipline.
* Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
* Proven expertise in technical transfer, PPQ execution, and lifecycle management.
* Strong understanding of validation principles and regulatory requirements for process validation (FDA, EMA guidelines).
* Experience with change control, non-conformance resolution, and CAPA implementation.
* Excellent organizational, communication, and collaboration skills.
* Ability to work independently with minimal supervision and operate effectively across functional boundaries.
* Critical thinking and problem-solving abilities.
Additional Skills:
* Familiarity with Quality by Design (QbD).
* Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
* Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.
Seniority level
* Entry level
Employment type
* Contract
Job function
* Management
Industries
* Pharmaceutical Manufacturing
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