Quality Control Associate
Compensation: $164,410.00 - $164,410.00 /year *
Employment Type: Full-Time
Industry: Advertising/Marketing/Public Relations
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Quality Control AssociateRedwood City, CA
Kelly Scientific is looking for a Quality Control Associate to join the quality team to be a key player in all scientific and documentation aspects of product development, release, stability, and investigations in support of maintaining and improving processes within the department. direct-hire role What You'll Do
- Provide guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews.
- Provide guidance to test methods, equipment acquisition, sample plan definition, and validation development.
- Provide guidance and decisions on product development activities to ensure compliance with internal procedures and applicable regulatory or international standards.
- Document, analyze, and interpret QC and experimental data.
- Responds to internal and external customer inquiries and requests as relevant to product quality or integrity.
- Investigates customer complaints and obtains data for customer inquiries that are relevant to QC.
- Manages development or transfer of new QC processes or improvements to existing QC processes through implementation with minimal assistance, including implementation of new QC equipment, methods, procedures, and/or software.
- Conducts experimentation in the synthesis, characterization, and/or functional integrity of oligonucleotides or Raw Materials.
- Develops equipment and process validation plans related to QC.
- Recommends testing for manufacturing-related non-conformances and CAPAs.
- Management of contract testing labs for in-process and final release assays.
- Ability to identify customer needs and issues and develop realistic solutions to meet needs and solve problems.
- Ability to communicate recommendation and decisions across the organization.
- 3 + years in regulated environment or similar
- Knowledgeable in statistical analysis and design of experiments.
- Minimum of Bachelor s Degree in a scientific discipline or equivalent experience.
- Possess working knowledge of cGMP and/or ISO 13485 systems.
- Strong communication skills
- High degree of attention to detail
- Experienced with analytical method development and validation preferred.
- Analytical instrumentation experience preferred (e.g. ESI-MS, HPLC, ddPCR, bioburden testing, endotoxin testing, etc.)
As a worker today, it s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what s next is what we re all about. We know what s going on in the evolving world of work just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
At Kelly, we re always thinking about what s next and advising job seekers on new ways of working to reach their full potential. In fact, we re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.Job Requirements:* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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