Sr. QC Analyst, Cell-based Methods
Sr. QC Analyst, Cell-based Methods
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Job Description
Band
Level 3Job Description Summary
The Senior Analyst Quality Control Cell-based methods will support activities within the Quality Control department with a focus on cell-based methods such as Adventitious Agents rcAAV potency etc. This role will utilize laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs) QC Methods & current Compendia. This role is based 100% on-site.Location: Durhan NC #LI-Onsite
Shift: 1st. Some night and weekend work may be required
Job Description
- Executes routine and non-routine analysis for cGMP release and characterization testing using techniques including but not limited to cell-based methods (potency AA) PCR (ddPCR qPCR) Immunoassays (ELISA) chromatography (HPLC-UV HPLC-ELSD HPLC-MS)AUC compendial assays (Bioburden pH) and electrophoresis (CE Western Blot).
- Ensures assigned to specific disciplines but will support all necessary laboratory and assay functions including housekeeping safety logbook/equipment use and maintenance and updates to existing and authors new operating procedures.
- Capable of delivering to assigned work schedule with attention to detail and accuracy.
- Notifies management initiates (such as Laboratory Investigations) and authors minor events/discrepancies in the quality systems with little to no guidance from advisor or management.
- Understands the basic process improvement methodologies learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
- May facilitate training to other team members in the organization.
- Ensures calibrates and maintains lab and analytical equipment are performed within established period.
- Conducts review of logbooks and may perform reviews as assigned by management
- May assist in drafting technical documents such as Protocols / Report to support method verification/validations.
- Other related job duties as assigned
Essential Requirements:
- Bachelors degree in scientific disciplines such as Biochemistry Biology Microbiology or related field with 2 years experience in GMP environment.
- Developing professional expertise applies company policies and procedures to resolve a variety of issues.
- 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 the critically thinking troubleshooting and problem-solving skills.
- Normally receives general instructions on routine work detailed instructions on new projects or assignments.
- Excellent interpersonal verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.
- Self-motivated detail-oriented and willing to accept temporary responsibilities outside of core duties.
The salary for this position is expected to range between $ 32.12/hour and $59.62/hour.
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.
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
