Sr. Spclst, Quality Assurance

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Support The Company-Durham Site And 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:

• Product release of batches for a company-Durham Facility.
• Completion of tasks required to release batches such as DOM/SLED Review, QN and CR review, testing review, market restrictions review, and CBER submissions.
• Create batch specific documentation such as Health Authority monitoring reports or release-specific shipping documents, and prepare packaging or distribution requested batch certificates.
• Interface with technical, other quality tiers, release personnel, planning, warehouse, QPs, and problem-solving collaborative meeting groups to support release on time release group needs.
• Author, review, and approve local release SOPs, assist with providing product related information to support Change Requests, and complete change control release tasks.
• Serve as release SME (Subject Matter Expert) to support internal and regulatory audits.
• Support and lead department related initiatives associated with KPIs (Key Performance Indicators), process improvements, and other goal-driven directives— own project management opportunities, by leading and participating in process improvement, learning events, and/or business support initiatives, as guided or approved by Quality management.
• Consults on an as-needed basis with next-level manager on more complex release decisions and/or issues that impact other units with inter-related processes.
• Other duties as requested by Management.

• Bachelor’s degree (BA/BS) in Biology, Biochemistry, Chemistry, Engineering or other relevant discipline with a minimum of four (4) years experience supporting the Biotech/pharmaceutical manufacturing industry, specifically in operations, technical operations, validation and/or process Quality Assurance.

• Ability to quickly learn new digital systems and software versions.
• Has in-depth knowledge of cGMPs and domestic and international regulatory requirements.
• A high degree of problem-solving ability.
• Demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.

• cGMP experience with sterile, bulk or finished pharmaceutical/biotech manufacturing environments.
• Experience with release or disposition of Product, Raw Materials, and Components Release.
• Experience that include a variety of deviation/complaints, change control, release, regulatory, document control, master data management, laboratory, or manufacturing oversight experience. Not just one area.
• Experience with SAP, MRP/ERP systems and/or GLIMS.
• Flexibility to support on-call off shift and hyper-care related activities.

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