QA Investigation Specialist 1

Pine Pharmaceuticals•Town of Tonawanda, NY

2d•$25 - $27•Onsite

About The Position

Pine Pharmaceuticals is seeking a highly 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 the quality, consistency, completeness, and regulatory defensibility of quality investigations. The successful candidate will work with cross-functional teams to ensure investigations are thorough, evidence-based, and compliant with cGMP requirements, and will present and defend investigation strategies, conclusions, and supporting rationale during FDA inspections and other regulatory audits. The position also provides quality oversight of the GMP warehouse, contributes to quality and compliance initiatives, and supports continuous improvement and operational excellence. The role is onsite in a dynamic manufacturing environment and handles moderate-complexity investigations with limited to moderate oversight.

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 the ability to author complex GMP records.
Demonstrated experience with root cause analysis tools, including 5-Why, human error prevention, Ishikawa/Fishbone diagrams, and process flow diagrams.
Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.
Working knowledge of cGMP, FDA and 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 deviation and CAPA records from initiation through closure, including authoring, leading, and driving records 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, collect data, and perform 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 using appropriate investigation methods.
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 directly 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.
Assess CAPA effectiveness and communicate identified 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 in the eQMS in accordance with cGMP, internal SOPs, and industry standards.
Support continuous improvement and operational excellence.