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Title: Senior Quality Assurance Specialist
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Senior Quality Assurance Specialist
Compensation, Benefits, and Employment Type
- Duration – Contract – 12 months+
- Pay rate: 60-80/hr.
- Job Location: Cambridge, MA
- Job# bh11983
This position in the Quality Assurance group is responsible for the quality oversight of GMP manufacturing and release activities. The successful candidate will support daily GMP manufacturing and release activities involving compliance with applicable regulations for cGMP requirements. The candidate will perform manufacturing batch record and data review; assist in the implementation and execution of QA systems to support manufacturing of products for commercial use and/or clinical use.
- Perform manufacturing batch record, data review to support disposition of bulk drug product
- Prepare compilation packages for the bulk drug product to support the release and disposition of product
- Review associated work orders, inventory sheets, log books associated with the manufacturing area
- Support raw material disposition including raw material packet review, release in SAP
- Provide review/approval of various SOPs, validation protocols and reports
- Leverage quality systems Unplanned Events, CAPA, Change Control, OOS/OOT’s to support lot release
- Working with key stake holders Initiate and support the closure of the above systems
- Resolves manufacturing issues as they arise in an efficient and effective manner
- Performs walkthroughs and audits as required
- Supports additional QA tasks or participates in projects as assigned which could include Inspection
- readiness activities, training administration, conducting classroom training and oversight of QC cGMP related documentation
- Participate on various project teams as assigned
- Assure that manufacturing operations are in compliance with cGMP regulations
- Perform suite release of the manufacturing area
- Support additional QA tasks or projects as assigned
- BS degree or higher in Biology or Chemistry preferred
- 5-10+ years of experience in a GMP environment (commercial experience preferred Batch Record review experience preferred)
- Previous experience with Quality Systems preferred
- Understanding of FDA, EMA and ICH quality requirements
- Candidates must be self-motivated, and have a strong attention to detail with the ability to multitask
- Excellent written and oral communication with exceptional organizational skills
Demonstrated ability to work in a team environment as well as manage projects independently
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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