Senior Quality Control Manager

---

Job description

Kelly Services is actively recruiting for a Senior Quality Control (QC) Manager for a Direct Hire (perm) opportunity located in Chicago, IL.

This opportunity is with a fully-integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline.

Essential Duties & Responsibilities:

• Serves as the Subject Matter Expert for all test procedures related to protein products
• Lead a team of analyst, stability coordinator and reviewer who are working on in-process, release and stability tests
• Troubleshooting of instrumentation issues
• Review/Approve electronic and written data and documents
• Provide evaluations of test and validation data results for regulatory submissions
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Oversee investigations regarding OOS and deviations to analytical procedures, including the development of CAPAs
• Participate in validation testing for system implementations and updates documents (SOPs, reports, protocols, specifications, etc.,) route for review and approval, issue effective SOPs and obsolete older SOPs.
• Initiate and carry out laboratory change controls
• Impart training to lab analysts, reviewer, stability coordinator etc.

Position Requirements and Qualifications:

• Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 15+ years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master's degree in above areas with 12+ years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 10+ years in a management role.
• Previous experience in a cGMP laboratory.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Experience with OOS and Laboratory Investigations, Deviations, Change Controls and CAPAs.
• Demonstrated expertise in cGMP, ICH, USP/EP, and other global compendial regulations and guidance
• Strong background in technical writing.
• Ability to collaborate with QC chemists, R&D, and other departments to facilitate management of release and stability testing.
• Excellent organizational and time management skills.
• Continuous improvement mindset.
• Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
• Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).
• Work environment includes office and laboratory.
• Must be able to lift at least 25lbs.
• Ability to work under pressure and meet deadlines
• High-paced environment structured to meet ambitious project goals

Please note:

• Must be able to work extended hours or weekend hours as requested.
• Some travel may required

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

]]