29 days old

Quality Control Manager

Kelly Services
Long Island City, NY 11101
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a **Direct Hire** opportunity to work as a **Quality Control Manager** located in **Long Island City, NY** .

**Job Summary:**

The **Quality Control Manager** leads all Quality control activities for biologics, devices and combination products for the company and also manages the respective instrumentation and methodology development. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness. This SME Manager role will also be required to perform analytical testing. and provides SME analytical testing support including execution of analytical testing.


+ Establish and Manages a GMP QC biochemistry\biologics and device, laboratory testing environment.

+ Manages the activities of QC in conjunction with supervisory and analytical staff (scheduling and assigns/prioritizes laboratory activities), performs analytical testing where appropriate and manages inspection and compendial testing on chemical/ products and raw materials.

+ Manages, reviews and/or performs Quality Control system activities such as in process, release and stability testing, information management, investigations, method validation, method transfer, instrument qualification, corrective actions / preventive actions management. Authors and approves SOPs, protocols, reports and data summaries.

+ Represents QC cross-functionally, provides technical subject matter expertise based on experience with release and stability testing, applies sound scientific judgement based on experience and knowledge of manufacturing and laboratory testing operations.

+ Develops and implements QC related components of quality management systems aligned with project schedules. Oversees the effective utilization of QMS by laboratory personnel, develops and maintains compliance metrics and reports to management.

+ Maintains and improves Quality Control GMP compliance and documentation, ensures data integrity of QC data for support of regulatory submissions.

+ Works in collaboration with internal Quality Assurance, Manufacturing and Contract Manufacturing and Testing Organizations to develop and maintain robust systems for sample tracking, data handling and reporting of metrics. Proposes and supports continuous improvement projects within QC.

+ Accountable for thorough, well documented and timely laboratory deviation / investigation reporting. Assembles and report laboratory metrics outside the QC organization.

+ Effectively utilizes Change Management to develop and execute continuous improvement initiatives within QC.

+ Authors / reviews applicable sections of regulatory documents as needed, supports responses to questions from regulatory authorities and represents QC during inspections.

+ Carries out direct supervisory responsibilities where applicable. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining.

+ Assures in collaboration with Quality Assurance that applicable employee training is completed and documented.

+ SME in cGMP/ISO vendor audits, as required.


+ Bachelors degree in biochemistry, biology, or related disciplines and 7-10 years of experience in a Biologics, Biopharmaceutical, and/or Biotechnology environment; or equivalent combination of education and experience.

+ Prior experience working in a cGMP environment required.

+ Must be proficient with QMS deployed to support GMP quality operations

+ Experience with leading development and implementation of methods used in testing of Biopharmaceutical products raw materials based on FDA/ICH guidelines and respective compendia.

+ Familiarity with content and providing strategic support for submission of regulatory documents and responses.

+ Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.

+ Ability to effectively manage and perform job responsibilities under minimal supervision.


**Email Aarti Patel at . Please be sure to include the name of the job you are interested in and location.**

**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.

**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. (
Posted: 2022-05-27 Expires: 2022-06-27

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Quality Control Manager

Kelly Services
Long Island City, NY 11101

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