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Description:
20% BRR
80% Analytical focused
• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
• Serves as QA Lead for clinical and commercial projects.
• Leads quality investigations/deviations/quality event escalation meetings and effectively communicates and escalates major and/or critical events to upper management in a timely manner.
• Reviews and approves method validation and/or transfer documents, including protocols, reports, methods, change controls, and specifications for small molecules and/or large biologics for analytical operations and contract labs/manufacturers across the clinical and commercial supply chains.
• Reviews manufacturing records, environmental monitoring, and quality control data for in-process and finished products.
• Reviews method validation-related data in CMC sections of NDA / global filings.
• Responsible for maintaining current knowledge of the Compliance Program and applicable company standard operating procedures for areas of responsibility.
• Interfaces with operating entities and contract partners to address documentation and compliance issues and ensure successful project completion.
• Review stability documents and contribute to APQR
• Reviews and improves existing quality procedure workflows and identifies areas of improvement for efficiency and compliance.
• Responsible for providing quality metrics, trend reviews, and risk assessments.
• Participates in projects, initiatives, and process improvements.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections.
Skills:
analytical chemistry, method validation, HPLC, UPLC, tech transfer, quality assurance, deviation
Qualifications:
•10 years of experience in a GMP environment-related field (analytical laboratory experience, specifically method development or method validation) and a BS or BA.
• 3+ years of relevant experience (analytical laboratory experience, specifically method development or method validation) and an MS.
• Prior experience in the pharmaceutical industry is required - preferred small molecule, oral solid dose, but open to large molecule.
Batch record review experience is a plus.
• Possesses experience/knowledge in laboratory controls, method validation, and method transfer guidelines per FDA/EU/ICH/USP/JP guidelines.
• Strong background in laboratory investigations (OOS, OOT, Atypical), deviations, and associated CAPAs.
• Proficient in applying FDA OOS Guidance, MHRA OOS Guidance, and general QA principles, concepts, industry practices, and standards.
• Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys).
• Working knowledge of Risk Management Tools (e.g., root cause analysis, decision trees, risk registers).
• Experience in a Pharma / Biotech GMP environment and a bachelor’s degree in chemistry, biology, or related scientific fields.
• Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations.
• Demonstrates excellent attention to detail and ability to meet high-quality standards required in QA Compliance consistently.
• Ability to work independently and effectively coach peers in a high-paced environment with tight timelines while maintaining accuracy and quality.
• Possesses critical thinking skills when making sound quality decisions based on risk management and available data.
• Has proven analytical and conceptual skills.
• Ability to effectively generate metrics and present
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
