Quality Control, Specialist

Novartis • Durham, CA

1d • Onsite

About The Position

At Novartis, we are reimagining medicine to improve and extend people’s lives. 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. #LI-Onsite Shift: 1st Location: Durham, NC This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Requirements

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology or related field required.
• 5 years of experience in GMP environment
• 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

• Responsible for directing and executing method transfers/verifications and assisting in execution of bioanalytical (BAL) analysis for cGMP release and characterization testing using techniques including but not limited to CE-SDS, SDS-PAGE and CZE methods.
• Supports BAL assay onboarding/execution, including drafts and maintenance of QC SOPS, forms, protocols, reports, Analytical Master Plans and change controls.
• Reviews and approves data for reports and specification compliance; supports and leads resolution of nonconformances (SSFs, deviations, OOS/OOT/OOE investigations)
• Assist with enrollment of vendors, ordering reagents and consumables for new assays.
• 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.
• Performs qualifications, maintenance and trend analysis of bioanalytical methods assays/critical 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.
• 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