- The QC Analytical Senior Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.
- The Senior Analyst works independently on assays they have mastered and performs advanced assays for multiple products. Work assignments will encompass performing and documenting activities and requires the ability to recognize deviations from approved procedures. Good record keeping, organizational, and written and verbal communication skills are essential.
- The Senior Analyst is expected to demonstrate strong cGMP and compliance acumen, become a subject matter expert for regulatory inspections, and provide training and educational development of other staff.
- Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines
- Works independently on assays they have mastered
- Develops and maintains proficiency in a broad range of test methods
- Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations
- Evaluates data against defined criteria/specifications
- Actively applies knowledge in non-routine situations using a thorough understanding of the work processes and practices
- Identifies key issues in complex situations, analyzes problems, and makes sound decisions
- Assists in the revision of written procedures, method/equipment validation, and/or method transfers as assigned
- Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise
- Holds self and others accountable for adherence to department and company policies and practices
- Maintains a safety and quality focused culture
- 3+ years of experience in a cGMP/GLP laboratory
- 2+ years hands-on experience in separation sciences (HPLC, UPLC, CE)
- Ability to follow written instructions and to perform tasks with direct or minimal supervision
- Strong leadership skills demonstrated through past work history
- Use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel
- Good written and verbal communication skills
- Attention to detail and strong documentation skills
- Ability to contribute effectively in team environments and independently
- 3-5 years of Quality Control laboratory experience
- 3-5 years of hands-on experience in separation sciences (HPLC, UPLC, CE)
- B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).
- Waters HPLC, Waters UPLC, Dionex HPLC, Sciex PA800, ProteinSimple iCE3, UV/VIS Spectrophotometer, pH Meter
- Internal and External Quality Assurance
- Manufacturing
- Scheduling and Sample Management
- Stability and Critical Reagent Management
- Not applicable to this position
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The Senior Analyst works independently on assays they have mastered and performs advanced assays for multiple products. · The Senior Analyst is expected to demonstrate strong cGMP and compliance acumen, become a subject matter expert for regulatory inspections, and provide traini ...
Novato2 weeks ago
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The QC Analytical Analyst is responsible for the timely completion of lot release, · stability, · and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures. · Performs biochemical/physical/chemical analyses of tes ...
Novato, CA6 days ago
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The QC Analytical Analyst is responsible for timely completion of lot release, stability, · and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines.Performs biochemical/physical/chemical analyses of test samples under cGMP to ...
Novato1 week ago
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The QC Analytical Senior Analyst works independently on assays they have mastered and performs advanced assays for multiple products. The Senior Analyst is expected to demonstrate strong cGMP and compliance acumen and provide training and educational development of other staff. · ...
Novato, CA2 weeks ago
-
The QC Analytical Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures. The Analyst works independently ...
Novato $48,000 - $82,000 (USD) per year1 day ago
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++ The QC Analytical Analyst is responsible for the timely execution of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products in accordance with cGMP guidelines. · +Perform biochemical, physical, and chemical analyses of test samples ...
Novato1 week ago
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The QC Analytical Analyst performs biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. · Performs biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. · Works independently on assays they have ma ...
Novato6 days ago
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The QC Analytical Analyst is responsible for the timely completion of lot release and stability testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.Performs biochemical/physical/chemical analyses of test samples under cGMP ...
Novato, CA1 week ago
-
The QC Analytical Analyst is responsible for timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products under cGMP guidelines. · Performs biochemical/physical/chemical analyses of test samples. · Develops proficiency i ...
Novato1 week ago
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The QC Analytical Analyst is responsible for the timely execution of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products in accordance with cGMP guidelines. · This role operates with minimal supervision and requires strong technica ...
Novato, CA1 week ago
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The QC Analytical Senior Analyst under minimal supervision responsible timely completion lot release stability non routine testing pharmaceutical drug substances drug products adhering cGMP guidelines procedures. · Performs biochemical physical chemical analyses test samples unde ...
Novato2 weeks ago
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The QC Analytical Senior Analyst is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures. · Performs biochemical/physical/chemical analyses of ...
Novato6 days ago
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The Senior Analyst, Quality Control Analytical is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures. · ...
Novato2 weeks ago
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The QC Analytical Senior Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.The Senior Analyst works i ...
Novato2 weeks ago
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The Senior Quality Control (QC) Analytical Analyst is responsible for the timely execution of lot release, · stability, and non-routine testing of pharmaceutical drug substances and drug products in compliance with cGMP guidelines.Perform biochemical, physical, and chemical analy ...
Novato2 weeks ago
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The Senior Analyst, Quality Control Analytical is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures. The Senior Analyst works independently ...
Novato1 day ago
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The Senior Analyst, Quality Control Analytical is responsible for the rigorous execution of lot release, · stability and non-routine testing of pharmaceutical drug substances · and products under strict cGMP guidelines. ...
Novato2 weeks ago
-
The QC Analytical Senior Analyst, under minimal supervision, is responsible for the timely completion of lot release, · stability,and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines · and procedures. · Performs biochemical ...
Novato2 weeks ago
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The QC Analytical Senior Analyst is responsible for the timely completion of lot release and testing of pharmaceutical drug substances and drug products under cGMP guidelines. The job involves working independently on advanced assays for multiple products with minimal supervision ...
Novato2 weeks ago
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-12 month contract · -Pay: $ /hr · SUMMARY · The QC Analytical Senior Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guideli ...
Novato1 day ago
Senior Quality Control Analyst - Novato - TalentBurst, an Inc 5000 company
Description
Title: Senior Analyst, Quality Control Analytical
Location: Novato, CA
Duration: 12+ Months
Summary:
Responsibility:
Required Skills:
Desired Skills:
Education:
Equipments:
Contacts:
Supervisor Responsibility:
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