QA Visual Inspection Specialist I - Global Impact

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Vor Ort; USD 60.000 - 85.000; Vollzeit

Zusammenfassung

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist I – Visual Inspection to provide QA oversight of VI activities and support cross-functional improvements. The role reports to the Sr.

Director, Quality and follows a 1st shift Monday–Friday schedule (8:30am–5:00pm). You will monitor production, review batch records, and ensure labeling and packaging quality in line with FDA regulations and ICH guidelines.

Qualifikationen

• High school diploma required.
• Strong organizational skills and attention to detail.
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience with ICH.
• Ability to apply basic scientific principles to solve operational quality tasks.
• Scientific, technical, and mechanical subject matter comprehension and aptitude.
• Able to articulate scientific and technical subject matter.
• Must maintain visual qualifications: 20/20 vision (corrected or uncorrected) and color discernment.
• Ability to work in a dynamic, fast paced environment.
• Excellent verbal and written communication skills.
• Proficiency in MS Office including Word, and Excel.

Aufgaben

• Provide QA oversight and support of Visual Inspection activities.
• Coordinate with cross-functional teams to improve procedures for VI, AQL, labeling, packaging, and final product release/shipments.
• Monitor production and visual inspection schedules and communicate potential delays.
• Inspect final packaged lots, bulk packaging, and final product sampling/retains.
• Create, review, and approve final product shipper and vial labels.
• Maintain final product retain program and VI qualification kits.
• Write or revise Standard Operating Procedures and support training.
• Schedule and prioritize activities with VI, PM, MM, QA teams.
• Assist with batch disposition meetings and cross-functional project teams.

Kenntnisse

Strong organizational skills

Attention to detail

Excellent interpersonal skills

Excellent written and verbal communic

Articulate scientific/technicalsubject

Ausbildung

Bachelor’s Degree in a relevant scientific field

Tools

MS Office (Word, Excel)

Jobbeschreibung

PCI Pharma Services in Bedford, NH is seeking a QA Operations Specialist I – Visual Inspection to provide QA oversight of VI activities and support cross-functional improvements. The role reports to the Sr.

Director, Quality and follows a 1st shift Monday–Friday schedule (8:30am–5:00pm). You will monitor production, review batch records, and ensure labeling and packaging quality in line with FDA regulations and ICH guidelines.