Senior Quality Associate

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 required

Full-Time