Job Title: QA Associate Line Support

　　Location: Iron Station, NC area

　　Hours / Schedule: Split 2nd / 3rd shift Monday - Thursday 6 PM to 3 AM, Friday 6 PM to 10 PM

　　Type: Direct Hire

　　Responsibilities:

　　Perform QA line verifications prior to the start of every packaging lot. Monitor Packaging operations along with all associated documentation (records, cleaning tickets, logbooks, etc.) Support operations by reviewing and approving notations to documents at time of generation. Perform record review as a supplemental function. Act as QA liaison for all Packaging related events.

　　Review in-process and completed documentation.

　　Review and approve notations to in-process and completed documents.

　　Perform QA Line Verifications prior to line release in Packaging.

　　Interact closely with Packaging to minimize # of documentation errors and Deviations by proactively responding to situation as they occur.

　　Facilitate record corrections to support production and batch release.

　　Interact and coordinate with other departments as necessary to successfully complete job tasks and assist with resolution of issues.

　　Adhere to and enforce internal quality systems and procedures.

　　Utilize knowledge of SOPs and GMPs to resolve quality issues.

　　Interact positively within Production Support Team and Packaging departments.

　　Communicate observations to QA and Packaging Management effectively.

　　Identify and quarantine non-compliant material.

　　Other duties as assigned.

　　Requirements:

　　BS Degree in analytical field of study; or four-year degree with sufficient credit hours in analytical studies to equal a minor degree; or five (5) years of applicable experience.

　　Relevant work experience may be considered as a substitute for education requirement.

　　Relevant experience in pharmaceutical environment.

　　Leadership qualities, interpersonal and team building skills a plus.

　　In-depth knowledge of FDA regulations related to plant operations.

　　Good problem solving, organization, documentation and communication skills.

　　Ability to perform essential functions as listed above.

　　Good working knowledge of PCs and Microsoft applications, QAD, and Trackwise system.

　　Ability to occasionally lift 50 pounds.

　　Benefits:

　　As this is a direct hire with our client, System One benefits described below would not apply to this role. Benefits program with the client would be those applicable to this role.

　　#M3

　　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.