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7 days old

Quality Control Manager

Kelly Services
Cumberland, RI 02864
**We are Kelly Science and Clinical,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a small customer focused generic oral solid CDMO with a strong track record of meeting aggressive development and commercialization timelines that has served small to mid-sized pharma companies over the past 16 years. Our client has helped their customers receive many product approvals, including 10 in the last 3 years. We attribute this success to company-wide focus on quality, customer service and meeting timelines.


**Position Title: Quality Control Manager**


**Overview**


Our client is a privately held pharmaceutical company that develops generic drug products via the ANDA process for itself and partnerships, as well as works on taking IND applications requiring drug product development and cGMP manufacturing through the ANDA and / or NDA process. Seeking Manager, QC a vital leadership role that is essential in supporting the companys progression of new pharmaceutical research into clinical development by manufacturing products for clinical trials in its beginning phases.


**Responsibilities may include (but are not limited to) the following:**


+ Head the collaboration between QC and Developmental Chemists personnel but also cross department collaboration regarding drug product development, commercial operations, commercial manufacturing, Quality Assurance, and Analytical Development.

+ Initial evaluation of QC laboratory including operational execution and resources.

+ Ability to identify, hire, train, and consistently coach staff while leading/developing managers.

+ Generate, review and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.).

+ Revise and manage technical transfer of methods from internal labs for raw material analysis, in-process testing, as well as API and Drug Product testing.

+ Review and report all QC data and generate Certificates of Analysis. Monitor and trend QC data generated by internal and contract testing labs.

+ Initiate ICH stability study protocols, execute and generate of interim reports.

+ Manage, write, and review Out of Specification/Atypical results/Out of Trend investigations, deviations, and CAPAs.

+ Oversee and manage contract testing labs, investigate, and troubleshoot method issues.

+ Determine stability sample requirements, develop stability protocols, and oversee execution of stability protocols.


**Education/Experience Requirements:**


+ Legally authorized to work in the job posting Country.

+ Bachelors degree in Chemistry, Pharmaceutical Sciences, or other related scientific field such as life sciences or drug product development.

+ Five to Seven (5 7) years of work/laboratory experience in the pharmaceutical industry, Quality Control as a manager or supervisor.

+ Ten (10) + years of experience in a regulated manufacturing or QC laboratory environment of analytical methods for pharmaceutical products.

+ Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment.

+ Solid understanding of GMP compliance, Quality Control CMC requirements for ANDAs, and other regulatory filings.

+ **Compensation Includes a base salary range of $125K- 150K (depending on experience), with a 15-20% yearly bonus and a Generous Benefits Package**


**EOE, including Disability/Vets**


**Why Kelly** **** **?**


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 interestsits 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.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-06-07 Expires: 2021-07-08

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Quality Control Manager

Kelly Services
Cumberland, RI 02864

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