Specialist, Quality Control - Raw Materials

Novartis • Durham, CA

1d • Onsite

About The Position

The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring conformance to established quality processes and standards for manufacturing and production.

Requirements

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment or 4 years’ at GTx.
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience required.
• Proven ability to work effectively in a team environment.
• Collaborates cross functionally with other departments to achieve site goals.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action including critical thinking, troubleshooting and problem-solving skills.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.

Nice To Haves

• Previous investigation experience a plus.

Responsibilities

• Execute routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to chromatography (HPLC, UPLC), AUC, SEC, compendial assays (pH, Conductivity, Osmolality), electrophoresis (CE, Western Blot) and assist with data review.
• Execute method verifications/transfers as required for various projects.
• Assist with enrollment of vendors, ordering reagents and consumables for new assays.
• Initiate all paperwork (LIMS, SOPs, assay forms) for testing and transfers of methods for projects.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance with specifications and reports abnormalities.
• Performs trend analysis of methods /environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Support department risk assessments and participate in audit walkthroughs.
• Participates in the preparation of investigations, summaries and reports.
• Reviews data obtained for compliance with specifications and reports.
• Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports / Analytical Master Plans for QC.
• Oversee special projects on analytical and instrument problem solving.
• May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports training of departmental personnel in appropriate techniques and related topics.
• Other related job duties as assigned.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level