Compliance Specialist II (Manufacturing/Quality)
Full Time
Swampscott, MA
Posted
Job description
Overview:
-
The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at Sanofi Framingham Biologics facilities. QA's main responsibility is to ensure adherence to CGMPs during manufacturing operations through a partnership with the site and direct engagement with daily operations activities. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality, and efficacy of Sanofi's products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Roles & Responsibilities:
-
The Senior Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team. Actively supports the QA Operations team by providing technical support. Completes Phenix/Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls. Ensure all safety requirements are being met Performs batch record and logbook review. Performs review of column packing and qualification records Review and approve CRs related to EBRs. Function as SME on challenges related to production requiring quality input. Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps. Issue action notices and conduct affiliated provisional release Conduct logbook audits against compliance requirements Review CV related documentation against specification
Job Skills:
-
Perform media/buffer and intermediate release Perform release of Cell Banks for forwarding processing (as applicable) Support cross-functional internal audit activities and conduct walkthrough inspections Execute containment activities Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs Maintain a high level of personal compliance with the required standards Knowledge in external agency regulations (FDA, EMA, etc.) Strong computer, verbal, and written communication skills. Strong technical writing skills. Effective time management, attention to detail, organizational skills, teamwork, and collaboration. Significant capability in problem-solving methodology. Knowledge of regulatory enforcement trends. Ability to work independently
Education & Experience:
-
Master's Degree & 2 years of experience or Bachelor's Degree and 4 years of experience in a Quality and /or another cGMP related field. Experience training and technically developing employees. Experience participating in external agency inspections. Experience in a Quality Assurance role. Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems. Experience with root cause analysis tools. Experience in quality systems Experience with Trackwise or equivalent system. Demonstrated experience with change control, CAPA, and deviation quality systems. Operations experience in one of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
learninglandscape.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, learninglandscape.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, learninglandscape.com is the ideal place to find your next job.