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Job Title: QA Associate III

Location: Athens, GA

Type: Contract, Potential for extension or conversion to permanent

Responsibilities

• Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation.

• Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified.

• Information must be proactively shared across QA and the business including the on-going training of junior team members.

• Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations.

• Works closely with others to determine root cause and potential preventative/corrective actions.

• Ensures support for the timely closure of investigations.

• Provides guidance directives regarding remediation activities required to continue production.

• Oversees execution of remediation/CAPA activities required to continue production or move a process along.

• Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue.

• Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.

• This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.

• Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities.

• Has authority to sign off/qualify/train junior staff on QA Operation responsibilities.

• Ensures all specifications are met and that requirements are completed and acceptable.

• Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.

• Analyzes and reports findings to appropriate departments.

• Works closely with others to recognize opportunities for improvement and drive change through the use of BIFI' Quality Systems.

  Requirements

• Capability to establish good relationships with others who have different values, cultural styles and perspectives.

• 5 to 7 years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.

• Project management experience

• Strong knowledge of relevant regulatory guidances.

• Demonstrated problem-detection and problem-resolution skills required.

• B achelors degree in Life Sciences or Engineering 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.