Senior Specialist Quality Assurance - Level III (Senior)

Job Title: Senior Quality Assurance Specialist III

Duration:

1 year assignment

Location:

100% Onsite - 5325 Old Oxford Road, Durham, NC 27712

Shift:

M-F 8am - 5pm

Pay Range: $50/- $55/hrhr. (38% Markup)

Qualifications:

Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry.

Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.

Must have 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.

Responsibilities:

Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.

Reporting to the Quality Assurance Organization, will independently manage project assignments.

Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.

Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.

Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.

Ensure all aspects of the project proceed in compliance with cGMP, regulations, and the Company's Quality Management System.

Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).

Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.