System One
Title: QA Associate / Specialist Location: Medford, MA Schedule: Monday-Friday 8am-4pm Type: Direct Hire Start date: ASAP Responsibilities: Perform administrative and support tasks to assist ASB Quality Systems Manager in maintaining all key ASB Quality Systems including but not limited to; Document Control, Training and Qualification Management, Deviation, CAPA Management, Vendor Qualification and Management, Audits and Inspections, Equipment Qualification and Management, Computer System Validation, Archival and Records Management, Tracking and Trending Review SOPs for administrative accuracy, adherence to SOP and template requirements, appropriate signatories, and to ensure appropriate allocation to training curricula Ensure version change history is maintained Prepare documents for Quality Systems Manager and ASB Management review and approval Maintain schedule of recurring training or qualification related events, including annual GxP training, CV and Job Description review Track deviation and CAPAs to completion according to approved target completion dates, and ensure Effectiveness Checks are performed by the due date when required Ensure QA audit of study data, in-process/critical phase, and reports are scheduled and completed by Quality Systems Manager.
Assist in scheduling, tracking, coordinating, and completion of Vendor Qualification events Assist GLP Archivist, Study Personnel, and Quality Systems Manager in preparing records for transfer to archival Maintain archive inventory and status of archived materials Requirements: B.A.
or B.S.
with 1-5 years of industry experience Knowledge of GLP and GMP regulations for a bioanalytical laboratory Experience with equipment and software validations, internal and external audits Joule, a System One division is a leader in specialized workforce solutions and integrated services.
With more than 6,000 employees and roughly 50 offices throughout the U.S.
we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.
For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.