Quality Control Manager- Biotechnology
Company: Michael Page
Location: Brockton
Posted on: January 12, 2021
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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
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