QC Specialist/Sr Specialist
QC Specialist/Sr Specialist
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Job Description
Band
Level 2Job Description Summary
The Specialist Quality Control assists and supports the organization with compliance and ongoing preparation testing and monitoring of conformance to established quality processes and standards for manufacturing and production.Location: Durham NC #LI-Onsite
Job Description
Key Responsibilities:
- Executes routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to ddPCR ELISAs NGS and Western Blot.
- 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 to 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 participates in audit walk-throughs.
- Participates in the preparation of investigations summaries and reports.
- Reviews data obtained for compliance to 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.
- Oversees 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 technique and related topics.
Essential Requirements:
- Bachelors degree in scientific disciplines such as Biochemistry Biology Microbiology or related field required
- For Specialist: 5 years experience in GMP environment or 4 years within Novartis Gene Therapies
- For Senior Specialist: 8 years experience in GMP environment or 7 years within Novartis Gene Therapies.
- Excellent interpersonal verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.
- 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 critically 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.
The salary for this position is expected to range between $29.13/hr and $54.13/hr.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
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.
To learn more about the culture rewards and benefits we offer our people click here.
Company will not provide visa sponsorship for this position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Continued Learning Dealing With Ambiguity Decision Making Skills Gxp Industry Standards Laboratory Equipment Laboratory Excellence Quality Control (Qc) Testing Quality Control Sampling Self-Awareness Technological Expertise Total Quality ManagementRequired Experience:
Senior IC
Employment Type
Full-Time
