Principal Investigations Compliance Specialist (Manufacturing or Laboratories)
GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)
Reporting to the Manager, Technical Investigation and Writing, the Principal Investigator will lead investigations related to Biologics Manufacturing (i.e., Upstream and Downstream) to support clinical/commercial Biotechnology Products. The Principal Investigator will also be responsible for working with manufacturing and QA teams to agree on appropriate CAPAs as needed. In addition, the Principal Investigator may revise or create Standard Operating Procedures, Protocols, Risk Assessments.
ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)
• Lead major and critical deviations related to biologics Manufacturing or Laboratory Testing to support clinical and commercial biotechnology products.
• Subject Matter Expert in quality and compliance in the biopharmaceutical industry.
• Collaborate with GxP Subject Matter Experts to write, review, or edit technical GxP documents in a clear, concise format.
• Meet key timing commitments, with well-investigated and well-documented reports.
• Coordinate and follow-up with personnel/department managers where the event occurred to gather additional information, facts, documents and applicable data.
• Utilize root cause analysis techniques during the deviation investigation process and perform prompt and thorough investigation in compliance with associated regulatory requirements.
• Determine scope, root cause, and product impact of the event
• Determine appropriate CAPA plans to address identified deficiencies or prevent reoccurrences and potential nonconformances.
• Assist the Data Integrity Governance Committee in DI investigations
• Ensure Good Documentation Practices (GDocP) are followed.
• Assist in the retrieval and compilation of quality metric data for the investigative process.
• Understand and apply global regulations to processes to ensure compliance.
• Create, review and/or approve appropriate policies, directives and procedures in alignment with relevant governmental regulations and guidelines.
• Provide active participation during regulatory agency inspections, as needed.
• Assist Quality Compliance management maintain a state of inspection readiness and compliance.
• Perform other related tasks and assignments as needed and specified by management related to document generation and control.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)
• Excellent written and verbal communication skills required, including responsible business communication.
• Comfortable with ambiguity and can adapt style and tactics based on situation.
• Focus on achieving objectives within specified timeframe and to meet quality expectations.
• Knowledge of relevant GxP regulations and guidance to include but not limited to 21 CFR, ICH, EU GDP/GMP, PIC/S.
• Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
• Must be proficient with all MS Office applications.
• Ability to work independently and to make decisions based on experience.
EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)
• Minimum of a Bachelor’s degree in a Technical/Science related field (e.g. Biochemistry, Engineering, Chemistry, Biology, etc.) or equivalent is required; with 8-10+ years of experience in the biotechnology, pharmaceutical, (GxP) industry; or equivalent combination of education and experience.
• Training in investigations technique and root cause analysis tools (5 WHY, Fishbone analysis, Is/Is-Not, etc.). is preferred.
• Must have technical knowledge of Manufacturing procedures/processes in the Biologics space.
• Strong experience with investigations/technical writing.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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