QA Specialist II - Operations

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JOB DESCRIPTION:

Position Title: QA Specialist II – Ops/Floor Support

Location: Bedford, New Hampshire

Department: Quality Assurance Operations

Reporting To: QA Supervisor or above

Responsible For (Staff): no

The QA Operations Specialist II – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing.
• Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems.
• Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures. May include management from groups such as Operations, Facilities, Quality, and Materials Management.
• Batch record review for adherence to internal procedures and Good Documentation Practices
• Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product.
• Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient.
• QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications.
• Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Co-ownership of nonconforming material investigations.
• Review of Quality Control environmental and utility monitoring data and test results
• Review and approval of work orders impacting manufacturing facilities and utilities
• Root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
• Advise and coach internal customers on proper documentation of tasks
• Initiation of Quality Systems (deviations, CAPA, Nonconformances).
• Perform Acceptable Quality Limit (AQL) visual inspection of final drug product
• Support Visual Inspection, packaging, and labeling operations
• Create, review, and approve final product labels
• Perform inspection of final product retains
• SOP revision as it pertains to process improvements.
• Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
• Support internal, client, and regulatory audits and inspections.
• Obtain Qualified Trainer status on department specific training tasks; train new and less experienced team members.
• Recommend and support improvement ideas and projects
• Interact with clients during client visits
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

QUALIFICATIONS:

Required:

• Bachelor’s degree in a relevant scientific field.
• Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience.
• ASQ certification is a plus
• Exposure to RCA, technical writing, and working with quality related investigations

Preferred:

• ​Exposure to lean operation excellence highly desirable
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.