Quality Assurance Operations Specialist 1 - Visual Inspection

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Position Title: QA Operations Specialist I – Visual Inspection

Location: Bedford, New Hampshire

Department: Quality Assurance,

Reporting To: Sr. Director, Quality

Shift: 1st M-F (8:30am - 5:00pm)

The QA Operations Specialist I – Visual Inspection is responsible for supporting tasks and activities associated with Visual Inspection and final product sampling, packaging, storage, and shipment across the Bedford, NH site. Primarily responsible for maintaining timely product inspection such as Acceptable Quality Limits (AQL) and Bulk AQL, maintaining the final product retain program, and other tasks which support Visual Inspection from a QA and compliance perspective. The QA Operations Specialist I – Visual Inspection partners with other QA Operations functions, Manufacturing, Visual Inspection, Materials Management, and Project Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide QA oversight and support of Visual Inspection related activities

• Coordinate with cross-functional teams to continually improve procedures with respect to visual inspection, AQL, labeling, packaging and final product release/shipments.

• Support scheduling activities by monitoring the production and visual inspection schedules, and communicating factors that may impact scheduled activities

• Inspection of final packaged lots, bulk packaging, final product disposition functions, AQL inspection, and final product sampling and retains.

• Create, review, and approve final product shipper and vial labels

• Perform annual inspection of final product retains, and support the maintenance of the final product retain program

• Ensure training and qualification status is in good standing

• Review of batch records and supporting GMP documentation

• Ownership of writing or revising Standard Operating Procedures

• Maintain and evaluate current processes and procedures, and drive continuous improvement efforts

• Media Fill inspections

• Support maintenance of final product reject inventory, defect library

• Support maintenance of Visual Inspection Qualification kits

• Initiation and ownership of Quality Systems such as Events, Deviations, and CAPAs.

• Train and/or qualify new and less experienced staff members

• Work with cross-functional teams such as VI, PM, MM, and QA to schedule and appropriately prioritize activities.

• Support leadership in site harmonization efforts as they apply to VI and QA Operations

• Represent QA-VI on internal project teams, and other collaborative group activities such as scheduling and run readiness meetings and batch disposition meetings.

• Assist QA-VI team members with scheduling and prioritizing daily activities.
• Other duties as assigned.

QUALIFICATIONS:

Required:

• 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 working with international regulations such as ICH

• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks.

• Scientific, technical, and mechanical subject matter comprehension and aptitude

• Able to articulate scientific and technical subject matter

• Must be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products.
• Ability to work in a dynamic, fast paced work environment

• Honesty, integrity, respect, and courtesy with all colleagues

• Resilient through operational and organizational change 

• Exceptional organizational skills and attention to detail

• Excellent interpersonal skills and the ability to communicate well orally and in writing

• Proficiency in MS Office including Word, and Excel

• Excellent verbal and written communication skills required

Preferred:

• Bachelor’s Degree in a relevant scientific field is a plus.

• Minimum 2 years’ experience working in Visual Inspection, Quality Assurance, and/or Quality Control groups which support the manufacturing of pharmaceutical products highly desired.

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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.