QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 330pm-2am)

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The QA Operations Specialist I - 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, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The QA Operations Specialist I - 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, needed 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.
• Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to
• policies and procedures.
• 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.
• Assist in 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
• May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
• Advise and coach internal customers on proper documentation of tasks
• Assist in the 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
• Participate in 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.
• 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 2 years' experience in relevant GMP industry preferred.
• Equivalent combination of experience and education may be considered.
• Exposure to RCA, technical writing, and working with quality related investigations.
• 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.

• Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and

familiarity with ICH Q9 preferred.

• Scientific, technical, and mechanical subject matter comprehension and aptitude
• Able to articulate scientific and technical subject matter

Preferred:

• ASQ certification is referred.
• Strong organizational skills and attention to detail
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing.
• Proficiency in MS Office including Word, and Excel
• Ability to work in a dynamic, fast-paced work environment.
• Honesty, integrity, respect and courtesy with all colleagues
• Able to work with some limited supervision, able to escalate issues as needed.
• Is flexible and adaptable through operational and organizational change.

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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.