The QA Operations Specialist II – Floor Support

PCI Pharma Services; Bedford (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

PCI Pharma Services seeks a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight in a GMP facility in Bedford, NH. You will observe aseptic processes, perform AQL visual inspections, review batch records, and ensure regulatory compliance across manufacturing lines.

The role requires a bachelor’s degree in a scientific field with at least 3 years in GMP (1+ year in QA). Strong collaboration with cross-functional teams and experience with QA systems are essential.

Qualifications

• Bachelor’s degree in a relevant scientific field is required.
• Minimum 3 years’ GMP experience with at least 1 year in Quality.
• ASQ certification is a plus; exposure to RCA and quality investigations.

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release and real-time GMP documentation review.
• Consult with Operations, QC, Facilities/Engineering, PM and Materials to resolve issues.
• Conduct frequent walkthroughs and internal audits of manufacturing areas to ensure policy adherence.
• Perform batch record review for compliance with procedures and GDP.
• Review and disposition incoming materials and changes impacting manufacturing facilities.
• Lead or participate in deviations, CAPA and nonconformances within the quality system.

Skills

QA on-the-floor

GMP documentation

Visual inspection

Batch record review

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s degree in a relevant scientific field

ASQ certification

Tools

QMS software

Deviation/CAPA processes

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Date Issued:

August 18, 2026

Application Deadline:

August 25, 2026

Wage Level:

Salary

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) : Yes

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.