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Senior Quality Associate
Location:
Branchburg, NJ
Description:
Overview FlexBiosys, A Repligen Company manufactures custom bags and assemblies for the Life Sciences Industry. We offer expert design and custom manufacturing of single use bioprocessing products. We offer a comprehensive range of products that include bioprocessing bags, bottles, and tubing assemblies. All manufacturing is done in our state-of-the-art ISO 7 Cleanroom in Branchburg, NJ. Our Quality System is ISO 9001:2015 as well as cGMP standards. You will be part of a small team in Branchburg that is connected with the larger Repligen organization. You will be reporting to the Operations Manager as well as working with the Quality Manager. Responsibilities * Management of various product line CAPA programs. Facilitate CAPA closure across the organization and assist with completing corrective actions required * Perform Internal Audits, including scheduling, conducting and reporting audit findings, CAPA generation and management * Assist with maintenance of the Supplier Management Program for product lines and assist with conducting audits at vendor sites, when needed * Review batch records including monthly RO/DI and weekly Environmental Monitoring, when required* Perform QA review and approval of document change requests (DCRs) for revisions to production documents, engineering drawings and pertinent SOPs* Facilitate the writing and closure of failure investigations and deviation reports associated with batch record review* Perform raw material release for both Quality Control and Manufacturing materials, including raw material specification updates* Responsible for mentoring and overseeing at least one direct report employee* QA review of production and QC documentation, and support activities, such as raw material release and maintaining files Qualifications * Bachelor's degree in Engineering strongly preferred. Biology, Chemistry, or equivalent will be considered* Minimum of 2-3 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent* Must have attention to detail and strong organizational skills* Must have experience with report writing, SOP revision and following up on corrective actions with demonstrated success* Supervisory experience is a plus* Previous auditing experience is a plus* Some travel may be requiredPDN-9bed99b4-66e7-4e4d-83c2-99f3b2f5d521
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Senior Quality Associate is a Other Jobs Senior Quality Associate Job at Repligen located in Branchburg NJ. Find other listings like Senior Quality Associate by searching Oodle for Other Jobs Senior Quality Associate Jobs.
Senior Quality Associate is a Other Jobs Senior Quality Associate Job at Repligen located in Branchburg NJ. Find other listings like Senior Quality Associate by searching Oodle for Other Jobs Senior Quality Associate Jobs.