QA Investigation Specialist 1
About The Position
Pine Pharmaceuticals is seeking an experienced QA Investigation Specialist to provide hands-on support to the Quality Unit and ensure compliance with applicable regulatory requirements. The role leads, authors, and improves quality investigations, with an emphasis on their quality, consistency, completeness, and regulatory defensibility. The specialist works with cross-functional teams to ensure investigations are thorough, evidence-based, and compliant with cGMP requirements, and must be able to present and defend investigation strategies and conclusions during FDA inspections and other regulatory audits. The position manages Deviations and CAPA records from initiation through closure and reviews and approves investigations, CAPAs, and effectiveness checks. It also provides quality oversight of the GMP warehouse, supports inspections and audits, evaluates recurring trends and systemic issues, and contributes to continuous improvement and operational excellence. The role requires sound technical and scientific judgment, strong documentation practices, and the ability to assess evidence, risk, product and patient impact, and CAPA effectiveness.
Requirements
- Minimum 3 years of relevant experience in a regulated industry, including 2 or more years of deviation experience.
- Experience authoring and leading cGMP manufacturing investigations, deviations, CAPAs, and quality event records.
- Strong technical writing and documentation skills, including demonstrated ability to author complex GMP records.
- Demonstrated experience with root cause analysis tools, including 5-Why, human error prevention, Ishikawa/Fishbone analysis, and process flow diagrams.
- Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.
- Working knowledge of cGMP, FDA/EMA regulations, and quality systems.
- Experience supporting regulatory inspections, internal audits, and inspection-readiness activities.
- Ability to work onsite in a dynamic manufacturing environment and collaborate across multiple functions.
- Comfort handling moderate-complexity investigations with limited to moderate oversight.
- Ability to remain seated or standing for extended periods, work at a computer workstation and use a laptop or monitor for prolonged periods, and safely lift and carry items weighing up to 20 pounds.
Nice To Haves
- Bachelor’s degree in a STEM field preferred; a high school diploma or associate degree with an equivalent combination of education and work experience may be considered.
- Experience with electronic Quality Management Systems (eQMS) preferred.
- Experience with FDA regulations in 503B or pharmaceutical manufacturing preferred.
Responsibilities
- Own and manage Deviations and CAPA records from initiation through closure within Pine quality systems.
- Review and approve investigations, CAPAs, and effectiveness checks related to manufacturing, environmental monitoring excursions, equipment, facilities, and other compliance events.
- Conduct fact-finding, data collection, and technical assessments using manufacturing records, laboratory data, audit trails, equipment histories, and other applicable systems.
- Participate in investigation and CAPA review meetings and facilitate cross-functional teams in identifying root causes.
- Perform gap assessments and root cause analyses using structured problem-solving tools such as 5-Why, Fishbone, and FMEA.
- Assess product, process, equipment, and patient impact and evaluate risk as required.
- Develop or support CAPA plans that address identified root causes and ensure CAPAs are effective.
- Ensure deviation records are completed accurately and within established timelines.
- Recommend quality process improvements to increase efficiency and performance and prevent recurrence of incidents or events.
- Support internal and external inspections as required.
- Provide quality oversight of the GMP warehouse.
- Use technical, scientific, and professional judgment to assess CAPA effectiveness and communicate deficiencies to the supervisor and area management.
- Contribute to quality and compliance initiatives, including internal audits and audit responses.
- Identify and evaluate recurring investigation trends and potential systemic issues.
- Maintain documentation discipline within the eQMS and adhere to cGMP, internal SOPs, and industry standards.
- Contribute to continuous improvement and operational excellence.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
