We are currently searching for a skilled professional to join a well-known client's team as a Quality Control Manager in Long Island City, New York. This role will lead all Quality Control activities for biologics, devices, and combination products, as well as manage the respective instrumentation and methodology development. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
- Establish and manage GMP QC Biochemistry, Biologics, device, and laboratory testing environment
- Manage QC activities and systems in conjunction with supervisory and analytical staff
- Schedule, assign, and prioritize laboratory activities
- Perform analytical testing where appropriate and manage inspection and compendial testing on chemical, products, and raw materials
- Author and approve SOPs, protocols, reports, and data summaries
- Provide technical subject matter expertise based on experience with release and stability testing
- Develop and implement QC-related components of quality management systems aligned with project schedules
- Oversee the effective utilization of QMS by laboratory personnel
- Develop and maintain compliance metrics/reports to management
- Maintain and improve Quality Control GMP compliance and documentation
- Ensure data integrity of QC data for support of regulatory submissions
- Work in collaboration with internal Quality Assurance, Manufacturing/Contract Manufacturing, and Testing of organizations to develop/maintain robust systems for sample tracking, data handling, and reporting of metrics
- Provide thorough, well documented, and timely laboratory deviation and investigation reporting
- Assemble and report laboratory metrics outside the QC organization
- Utilize Change Management to develop and execute continuous improvement initiatives within QC
- Author and review applicable sections of regulatory documents
- Respond to questions from regulatory authorities and represent QC during inspections
- Interview potential employees
- Provide employee training and development
- Plan, assign, and direct work
- Collaborate with Quality Assurance that applicable employee training is completed and documented
- Complete SME in cGMP/ISO vendor audits
Minimum of 7 years of experience in a Biologics, Biopharmaceutical, and/or Biotechnology environment required, equivalent combination of education and experience considered
Prior experience working in a cGMP environment required
Proficient with QMS deployed to support GMP quality operations required
Experience with leading development and implementation of methods used in testing of Biopharmaceutical products, raw materials based on FDA/ICH guidelines, and respective compendia preferred
To be a best-fit your strengths must include:
Bachelor's Degree in Biochemistry, Biology, or related discipline required
About Advanced Clinical
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.