Senior Quality Assurance Specialist

Job Name: Senior Quality Assurance Specialist

Location: Durham, NC

Hours/Schedule: Mon- Fri 8am- 5pm

Type: Contract

Overview

Global pharma company looking to add experienced Quality Specialist to their growing team. Candidates must bring a BS Degree, 5+ years of Quality Assurance experience within pharmaceutical manufacturing, and experience with equipment and batch review qualification activities. This is not a validation or IT role.

Responsibilities:

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

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 our 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.

Consults on an as-needed basis with next level manager on more complex decisions.

Requirements:

Minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)

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.

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

Must have very strong relationship building skills.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.