Compliance Specialist II
76 New York Ave, USMA0118 Framingham, MA
This position will report to the Quality Manager and will assist in maintaining the quality systems and GMP compliance in support of ongoing operations at the Biosurgery manufacturing site.
Senior Compliance Specialist duties will include but not be limited to:
Perform all aspects of lot issuance (Batch Records, log books and log sheets), and management of theRecords Room, including filing.
Record Review (Batch Records and Log books In accordance with the relevant site release SOP and corporate standard.
Perform review of testing results in support of release of intermediates.
Perform QA presence on the floor in Manufacturing (oversight, Issuance, reconciliation, AQLInspection, as appropriate) .
Ensure compliance to the relevant SOP and corporate standards.
Participate in investigation of non-lot associated deviations, change controls (CCR), Environmental Monitoring System (EMS) Investigations, Action notices as required.
Participate in monthly walkthrough program and review pest control logs. Ensure that documentation and operations meet established requirements of cGMPs,
Internal SOPs and company policies. Draft and revise procedures (OCR) as required.
Support Archiving program, as needed.
Support additional Quality activities and tasks as assigned by Management.
Proficient in Microsoft Office.
Experience with Quality Systems.
Strong technical background in regulated products, cGMP.
Excellent communication skills both written and verbal.
Effective time management and organizational skills.
Ability to gown and enter clean rooms. Education: Bachelor' s degree (BS/BA) or equivalent in a scientific discipline with 5-7 years industry experience in quality or operations including experience in cGMP, pharmaceutical/medical device quality systems.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.