Kelly Services Quality Control Technician in Marlborough, Massachusetts
Quality Control Technician, Marlborough, MA
Kelly Services is currently seeking a Quality Control Technician for one of our top clients in Marlborough, MA.
Duration : 03/26/2018 – 03/29/2019
Hours : 40 hr/wk
Summary of Responsibilities
The QC Technician is responsible for the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing on development and commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). Interacts with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. Provides contribution to projects associated with drug substance and products.
Essen tial Functions Required for Job
Review and Approve drug substance and drug product (commercial and CTMs) analytical testing at contract laboratories.
Monitor stability activities including maintenance of master stability protocols and individual study plans, set up of stability studies, and assist in writing of timely stability reports.
Approve and issue component and/or drug product and packaged clinical trial material C of As.
Investigate and resolve analytical test failures (OOS and atypical results).
Monitor contract lab activities to ensure compliance and timeliness of C of As and reports.
Summarize and report laboratory performance metrics.
Perform specification and method changes.
Represent QC in cross-functional teams for Client products and projects.
Provide analytical support for manufacturing investigations as required.
Participate in audits, as required.
Contribute to company quality systems.
Assist in CMC section preparation for regulatory submissions
Minimum of Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or relevant field of study.
Minimum of Bachelor’s degree and 2 years of experience in an FDA-regulated biotechnology, pharmaceutical or medical device company with direct exposure to laboratory operations, documentation practices, and quality systems, or an advanced degree.
The desired candidate will have experience in testing pharmaceuticals and possess a good analytical background with great attention to detail. Client is a virtual company that outsources drug product manufacturing and testing. Experience in interacting with contract testing laboratories and other contract vendors is preferred.
Knowledge of analytical testing concepts and principles such as Liquid Chromatography.
Knowledge of current Good Manufacturing Practices (cGMPs) including laboratory controls and good documentation practices.
Must be able to work independently and as a member of cross-functional teams comprised of internal and/or external contacts.
Work hours are likely to include meetings scheduled outside of normal working hours. Demands during peak time my require work hours outside of normal business hours.
If you are interested in the position, please apply to this posting with an updated resume. Qualified candidates will be contacted. Thank you for your time and I look forward to working with you.
Lauren Rogers, Kelly Services Scientific Recruiter
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm