Quality and Compliance Specialist

Piramal Pharma•Riverview, MI

2d•Onsite

About The Position

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC) in Riverview, Michigan, is seeking a Quality & Compliance Specialist to join its Quality Assurance team. The position supports manufacturing operations at a 24x7 facility and helps implement, execute, and maintain manufacturing-related Quality Systems so the site complies with USFDA and other international regulatory requirements. Assignments include material release and review and implementation of documentation supporting site Quality Systems and operations under GMP requirements. The role supports clinical and commercial manufacturing and process development. It is shift-based, with weekend and holiday work as needed on a rotating schedule.

Requirements

Bachelor’s degree in physical or biological sciences or engineering and at least 1 year of experience in pharmaceutical operations/quality or another GMP environment; alternatively, an associate’s degree and at least 2 years of experience in pharmaceutical operations, regulated life sciences, or quality assurance; alternatively, no degree and at least 3–5 years of relevant experience, or an equivalent combination of Quality and technical education.
Knowledge of GMP requirements, including 21 CFR Parts 11, 210, and 211, Annex 11, and ICH Q7, Q9, and Q10.
Strong computer skills, including MS Office (such as Word, Visio, and Excel), relational databases, reporting, and statistical tools.
Proficiency in TrackWise, SAP, and Master Control, or experience with document management and ERP systems.
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
Strong attention to detail.
Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
Strong analytical skills and ability to work independently against multiple deadlines.
Ability to complete tasks independently and notify a supervisor about decisions outside established processes.
Willingness to work a shift-based schedule, including weekends and holidays as needed on a rotating schedule.

Nice To Haves

Experience interacting with the FDA or other regulatory agencies.
Knowledge of manufacturing quality, including manufacturing, packaging, facilities, critical systems, validation, and SPC.

Responsibilities

Review batch production records, analytical test packages, cleaning records, and related documentation to confirm GMP compliance and manufacturing under approved SOPs; address batches pending approval due to GMP errors and related corrective-action investigations.
Review in-process and finished-product batch records and intermediate analytical records.
Release intermediate products based on conformance with specifications and completion of associated documents.
Walk production areas to promote adherence to current GMP; address corrections or deviations with production staff in real time and explain their impact and prevention.
Review production-generated batch data in real time during the shift, including executed batch records, temperature recordings, cleaning records, in-process checks, equipment status tags, and logbooks, for accuracy, completeness, and data-integrity compliance.
Support QA administrative work, including issuing current master production records and labeling to manufacturing, filing completed batch, testing, and cleaning records, and maintaining document-tracking systems.
Support internal and external audits and regulatory inspections through data gathering, interviewing, or escorting auditors; conduct internal audits, housekeeping inspections, and walkthroughs of Quality Systems and operations.
Audit Quality Systems and records, create documentation as needed, follow up on corrective actions, explain site quality systems and operations during audits, and participate in formal responses to audit reports as appropriate.
Support Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports; participate in preparing or reviewing analytical methods validation, cleaning validation, and process validation documentation.
Ensure generated data complies with approved internal procedures; participate in continuous improvement initiatives related to production and quality; provide operational or system information to internal or external clients as requested.
Identify trends in batch deviations and corrections and present corrective actions to reduce their number; assist with implementation of data-integrity procedures and compliance in Production.
Perform routine and ad hoc Quality Systems metric reporting and analysis, and prepare metrics and trend analyses for management review.
Participate in the Risk Management program, including updating risk analyses, participating in applicable teams, and maintaining Risk Management documents.
Perform other related assignments and projects as required.