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Actalent
Lexington
Job Description + Join our dynamic team as a QC Manager to support external contract organization activities, ensuring all GMP QC testing needs are met efficiently. + Provide crucial internal support to CMC Operations to aid in the development, manufacture, and release of materials. + This includes method transfer, qualification, validation, and ma
Job Source: ActalentBRIOHEALTH SOLUTIONS INC
Boston, MA, United States
Job Description At BrioHealth Solutions, we push the limits of what technology can do to improve lives for patients suffering from advanced heart failure by challenging ourselves and each other to make tomorrow better than yesterday. We need fresh ideas and inclusive insights to continue to be a leading medical technology innovator. We strive to s
Job Source: BRIOHEALTH SOLUTIONS INCAdecco US, Inc.
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Adecco Staffing is assisting a well-known Medical Device Manufacturing facility in Chelmsford MA with their needs for Quality Control Inspectors on 1st and 2nd shift! This is a temp-to-hire opportunity. **Hours -** **1st shift** 5:00am-1:30pm **2nd Shift** 1:00pm-9:30pm **Pay -** **1st shift** $22hr **2nd Shift** $ 24.20hr **JOB SUMMARY:** With lim
Job Source: Adecco US, Inc.Sun Pharma
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Job Summary The Associate Quality Control - Compliance role is a dual function role. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs various quality control tests on raw materials, in-process and final product using approved test methods, Standard Operating Procedures (SOPs) and works in acco
Job Source: Sun PharmaModerna Therapeutics
Norwood, MA, United States
Moderna is seeking a Manager, Chemistry to support our Quality Control team specializing in Individualized Neoantigen Therapy (INT) clinical production. This position will be based in our cGMP Manufacturing site in Norwood, MA. The individual in this role will focus on managing QC Analysts and supervisors in support of Analytical activities includi
Job Source: Moderna TherapeuticsApex Systems
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Sr. Quality Control Analyst 2027519 Location: Boston, MA (Onsite) Therapeutic Area: Neuromuscular Job Overview: The Senior QC Analyst ensures quality control through analytical testing, method validation, and compliance with SOPs, playing a pivotal role in releasing cell therapy products. Primary Job Responsibilities: Leads in ensuring product
Job Source: Apex SystemsSun Pharmaceutical Industries, Inc.
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Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Create Alert Company: Sun Pharmaceutical Industries, Inc (USA) Job Summary The Associate Quality Control - Compliance role is a dual function role. The role is divided between QC compliance activities and QC laboratory GMP testing activities. Performs v
Job Source: Sun Pharmaceutical Industries, Inc.Eurofins
Boston, MA, United States
Company Description The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life
Job Source: EurofinsLexington
Job Description
+ Join our dynamic team as a QC Manager to support external contract organization activities, ensuring all GMP QC testing needs are met efficiently.
+ Provide crucial internal support to CMC Operations to aid in the development, manufacture, and release of materials.
+ This includes method transfer, qualification, validation, and managing product shelf life.
+ Collaborate closely with PDAS, Manufacturing, CROs for technical transfer of testing methods and assays, and troubleshoot as necessary.
+ Ensure strict compliance with regulatory standards including FDA, EMA, and other agencies.
+ Develop and validate analytical methods for QC testing, implement quality systems for data integrity, manage release/stability data, and generate reports.
+ Work within multiple departments to address QC document reviews and manage documentation through eQMS systems like ZenQMS.
+ Track stability time points, create and update tables for stability data, and manage change controls, deviations, and CAPA within eQMS.
Hard Skills
+ mRNA
+ LNP
+ Microbiology
+ Stability Testing
+ Biologics
+ CMC
Job Type
This is a contract position with a duration of 9 Month(s).
Work Site
This is a fully on-site position in Lexington, Massachusetts.
Additional Skills & Qualifications
• Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field with 5-8 yrs experience within the biotech/pharma industries
• 3+ years of Analytical / Quality Control experience in a GMP environment
• Good understanding of cGMPs, ICH stability, and Regulatory Drug requirements
If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
Email Alert for QC Manager_ jobs in Lexington
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