QA Operations: Visual Inspection Specialist I

PCI Pharma Services; Bedford (NH); On-site; USD 60,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist I - Visual Inspection to support QA activities around visual inspection, product sampling, labeling, and final release.

The role collaborates with VI, Manufacturing, Materials Management, and Project Management to ensure AQL compliance, training, and CAPA initiation. 1st shift, Mon-Fri, in a regulated pharmaceutical setting.

Qualifications

• High school diploma required.
• Knowledge of FDA regulations (21 CFR Parts 210, 211 & 820) and ICH experience.
• Ability to apply basic scientific principles to quality tasks.
• Excellent scientific and technical communication skills.
• Able to maintain visual qualifications and discern product specs.
• Proficient in MS Office including Word and Excel.

Responsibilities

• Provide QA oversight of Visual Inspection activities.
• Coordinate procedures for visual inspection, AQL, labeling, packaging, and final release.
• Monitor production and inspection schedules and flag impacts.
• Inspect final packaged lots and retain samples; review batches.
• Create/approve final product shipper and vial labels.
• Maintain the final product retain program and CAPA support.
• Train and qualify new staff and support cross-functional teams.
• Participate in site harmonization for VI and QA operations.
• Represent QA-VI on internal project teams and run readiness meetings.

Skills

Strong organizational skills

Attention to detail

Excellent verbal and written skills

MS Office proficiency (Word, Excel)

Ability to communicate scientific/tech

Ability to work in dynamic environment

Integrity and professionalism

Ability to maintain visual tolerances

Education

High school diploma

Bachelor's degree in a relevant scientific field

Tools

MS Office (Word, Excel)

Job description

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist I - Visual Inspection to support QA activities around visual inspection, product sampling, labeling, and final release.

The role collaborates with VI, Manufacturing, Materials Management, and Project Management to ensure AQL compliance, training, and CAPA initiation. 1st shift, Mon-Fri, in a regulated pharmaceutical setting.