QA Investigation Specialist 1

Job Summary:

Pine Pharmaceuticals is seeking a highly experienced QA Investigation Specialist to provide hands-on support to the Quality Unit and ensure compliance with all applicable regulatory requirements.

This role will be responsible for leading, authoring, and improving the quality, consistency, completeness, and regulatory defensibility of quality investigations. The ideal candidate will have a minimum of three years of experience in deviation management and investigation writing within an aseptic manufacturing environment, with demonstrated expertise in conducting and documenting complex investigations.

The successful candidate will be highly skilled in root cause analysis, developing effective and sustainable CAPAs, and ensuring CAPAs are directly aligned with identified root causes. The individual must be capable of evaluating evidence, drawing scientifically sound conclusions, and clearly documenting rationale that can withstand regulatory scrutiny.

This individual will work closely with cross-functional teams to ensure investigations are thorough, evidence-based, and compliant with cGMP requirements. The candidate must also be comfortable presenting and defending investigation strategies, conclusions, and supporting rationale during FDA inspections and other regulatory audits.

Essential Responsibilities & Duties:

• Own and manage Deviations and CAPA records from initiation through closure (author, lead and drive) within Pine quality systems.

• Review and approve investigations/ CAPAs / effectiveness checks associated with including but not limited to manufacturing, environmental monitoring excursions, equipment, facility, and other compliance-related events.

• Conduct thorough fact-finding, data collection, and technical assessments utilizing manufacturing records, laboratory data, audit trails, equipment histories or any applicable systems.

• Participate in investigation and CAPA review meetings, facilitate cross-functional teams to identify root causes using appropriate investigation methods.

• Perform gap assessment and thorough root cause analysis using structured problem-solving tools (e.g., 5-Why, Fishbone, FMEA)

• Assess product, process, equpment and patient impact and evaluate risk as required.

• Develop and/or support CAPA plans that directly address the identified root cause and ensure CAPAs are effective.

• Ensure deviation records are completed accurately and within established timelines.

• Recommend quality process improvements to increase efficiencies and performance of systems, operations and personnel and prevent reoccurrence of incident or event.

• Support internal and external inspections as required.

Other Responsibilities & Duties:

• Quality oversight of the GMP warehouse

• Use technical, scientific and professional judgment for assessing the effectiveness of CAPAs and communicates to supervisor and area management when deficiencies are found.

• Contribute to additional quality and compliance initiatives, including conducting internal audits and audit responses.

• Identify and evaluate recurring investigation trends and potential systemic issues.

• Maintain strong documentation discipline within the eQMS, ensuring adherence to cGMP, internal SOPs, and industry standards

• Commitment to continuous improvement and operational excellence

Qualifications, Skills & Abilities Required:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.

• Strong technical writing and documentation skills with demonstrated ability to author complex GMP records

• Demonstrated experience in root cause analysis tools including but not limited to 5WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

• Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.

• Working knowledge of cGMP, FDA/EMA regulations, and quality systems

• Experience with electronic Quality Management Systems (eQMS) preferred

• Ability to work onsite in a dynamic manufacturing environment and collaborate across multiple functions

• Comfortable handling moderate-complexity investigations with limited to moderate oversight

Experience Required:

• Minimum 3 years of relevant experience in a regulated industry with 2+ year deviation experience.

• Experience with FDA regulations in 503B / Pharma manufacturing is preferred.

• Experience authoring and leading cGMP manufacturing investigations, deviations, CAPAs, and quality event records.

• Experience supporting regulatory inspections, internal audits, and inspection readiness activities.

Physical Requirements:

• Ability to remain seated or standing for extended periods as required.

• Ability to work at a computer workstation and use a laptop or monitor for prolonged periods.

• Ability to safely lift and carry items weighing up to 20 pounds.