Associate Specialist

Job Description

Associate Specialist, Quality Systems and Compliance

Primary Responsibilities:

Support Quality organization by performing tasks associated with the site’s goals and initiatives as they relate to batch release and Quality requirements and standards. This involves the items as listed below, but is not limited to the following:

• Perform Quality batch record review for the Facility.
• Support department related initiatives associated with KPIs (Key Performance Indicators), process improvements, and other goal-driven directives—participating in process improvement, learning events, and/or business support initiatives, as guided or approved by Quality management
• Author and review SOPs.
• Other duties as requested by Management.

Minimum Education Requirement and Experience:

• High School Diploma with minimum of (2) two years industry experience or BS degree.

Required Experience and Skills:

• Has in-depth knowledge of cGMPs
• Expected to possess a moderate degree of problem-solving ability.
• Detail oriented
• Able to perform work independently and within a team

Preferred Experience and Skills:

• Experience with electronic Batch Records (MES/PAS-X)
• cGMP experience in a sterile, bulk or finished pharmaceutical/biotech environment.
• Experience with release or disposition of Product, Raw Materials, and Components Release
• Experience with SAP, MRP/ERP systems and/or GLIMS
• Flexibility to support on-call off shift and hyper-care related activities.
• Bachelor’s degree (BA/BS) in Biology, Biochemistry, Chemistry, Engineering or other relevant discipline. #ERBG #MSJR VETJOBS TechnicianDurham

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a <