Quality Control Manager- Biotechnology

Company: Michael Page
Location: Brockton
Posted on: January 12, 2021

Job Description:

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryDevelop, implement and direct the Quality Control program. Ensure adherence to all cGMP policies and corporate standards. Maintain quality through internal and external inspection of raw materials and finished items purchased, as well as production operations and processes. Provide technical expertise and communications to other functional departments. Hold the responsibility for raw material and finished product release.Client DetailsPharmasol Corporation is a small to midsize privately held contract development and manufacturing organization (CDMO) of personal care and pharmaceutical products for prominent global brands and retailers in the health care and cosmetics industries. We are driven by our strong management team, continuous improvement philosophy and dedication to product quality and customer servicDescription--- Manages the day-to-day cGMP laboratory activities of QC analysts and scientists directed toward accurate and timely release testing of raw materials, intermediates and finished products.--- Provide expert guidance to Manufacturing, Production, R&D, and other departments regarding quality and cGMP issues to ensure compliance with regulated standards.--- Support FDA inspections, third party audits, and Regulatory submissions as they relate to QC Chemistry and Analytical Support Services.--- Evaluation of newly developed in-house methods or compendial methods for suitability and acceptability--- Ensures the successful transfer of new methods to QC and the validation/re-validation of existing methods and instrumentation are performed as required and in accordance with the Method Validation Program and applicable regulations.--- Lead and/or provide directional support to staff related to cGMP laboratory investigations (e.g., OOS/OOTr, deviation and CAPA).--- Contributes to the effective and efficient operations of the laboratory in terms of workflows, people flows, laboratory equipment, and staff training.--- Assists with talent recruitment and leads a highly motivated, efficient and effective team.--- Ensure EHS requirements being met within QC function .Other tasks assigned by superior.ProfileSkills & Experience--- Minimum of a Bachelor's degree in Analytical Chemistry or related scientific discipline and 8-10 years of GMP experience in the pharmaceutical or biotechnology industry.--- At least 5 years of experience with increasing responsibilities in management of cGMP laboratory operations and method validation, with a minimum of 3 years supervisory/leadership experience required.--- Excellent communication and writing skills is an essential requirement of this position.--- Knowledge of US FDA and EU standards--- QC lab operations and data management--- Strong Management Skill and leadership--- Responsible for the analytical testing and release of drug substance and raw materials in support of contract commercial manufacturing in a cGMP laboratory as a member of the Quality Control group. Duties include scheduling testing in accordance with disposition timelines, maintaining equipment, reviewing and revising cGMP documentation, monitoring trends, participating in lab audits and regulatory inspections.Job OfferJob Type: Full-timeBenefits:--- 401(k)--- 401(k) Matching--- Dental Insurance--- Disability Insurance--- Flexible Schedule--- Flexible Spending Account--- Health Insurance--- Life Insurance--- Paid Time Off--- Vision InsuranceSchedule:--- 10 Hour ShiftExperience:--- Pharmaceutical: 5 years (Required)Location:--- South Easton, MA 02375 (Required)Work Location:--- One locationThis Job Is:--- A job for which military experienced candidates are encouraged to applyCompany's website:--- www.pharmasol.comWork Remotely:--- No

Keywords: Michael Page, Brockton , Quality Control Manager- Biotechnology, Executive , Brockton, Massachusetts