QA Operations Specialist II — On‑Floor Quality & Compliance

PCI Pharma Services; Tennessee; On-site; USD 75,000 - 98,000; Full time

Job summary

PCI Pharma Services is seeking a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight for manufacturing and visual inspection activities in a GMP facility. You will perform real-time GMP documentation reviews, support room releases, and ensure adherence to quality systems during batch processing.

The role requires a Bachelor's degree in a scientific field and at least 3 years of GMP experience with 1 year in Quality; ASQ is a plus.

Qualifications

• Bachelor's degree in a relevant scientific field is required.
• Minimum 3 years' experience in GMP industry with at least 1 year in Quality.
• ASQ certification is a plus.
• Exposure to RCA, technical writing, and quality-related investigations.

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 (Operations, QC, Facilities/Engineering, Project Management, Materials Management) to resolve complex situations.
• Conduct frequent walkthroughs and internal audits 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 evaluation and disposition of intermediates, finish bulk drug substance and drug product.
• Review, approve and disposition of incoming materials such as consumables, excipients, and API.
• QA review and approval of new and revised GMP documents such as SOPs and raw material specifications.
• Act as first responder for on-the-floor quality issues with timely documentation and corrective actions.
• Co-ownership of nonconforming material investigations.
• Review QC environmental and utility monitoring data and test results.
• Review and approval of work orders impacting manufacturing facilities and utilities
• Root cause analysis using methodologies (fishbone, 5 whys, etc.).
• Advise and coach internal customers on proper documentation of tasks.
• Initiation of Quality Systems (deviations, CAPA, Nonconformances).
• Perform 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.

Skills

On-the-floor QA oversight

Interdepartment coordination

Audit execution

Root cause analysis

Quality trend monitoring

Education

Bachelor's degree in a relevant scientific field

ASQ certification (preferred)

Job description

PCI Pharma Services is seeking a QA Specialist II - Ops/Floor Support to provide on-the-floor QA oversight for manufacturing and visual inspection activities in a GMP facility. You will perform real-time GMP documentation reviews, support room releases, and ensure adherence to quality systems during batch processing.

The role requires a Bachelor's degree in a scientific field and at least 3 years of GMP experience with 1 year in Quality; ASQ is a plus.