Overview
Quality Assurance Manager Jobs in Waltham, Massachusetts, USA at Aequor
Client is only considering candidates located within commutable distance (30 miles maximum) from office.
Job Title:
QA Person in Plant
Contractor
Work Location:
Waltham, MA 02451 – 100% onsite role
Duration: 6 months contract
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Duties
Perform batch record review of investigational products manufactured at CMO partners.
Perform QA/client review for internal and/or CMO Quality System records, manufacturing documents, analytical methods, and qualification/validation documentation.
On-site oversight of CMO operations as needed.
Ensure all necessary documents/forms/records are authorized to facilitate movement of cell product to clinical sites
Support Manufacturing to collect and monitor key performance indicators of CMO and contract/external laboratories.
Review, maintain, and execute against Quality Agreements with the Supplier/CMO network.
Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.
Collaborate with cross-functional teams to communicate risks and implement corrective and preventive actions.
Support investigations into critical quality issues and product complaints. Facilitate identification of root cause, and development of appropriate corrective and preventive actions.
Suggest the development, implementation, and maintenance of quality systems, processes, and procedures related to GMP operations to mitigate compliance risks identified.
Other duties as assigned by manager.
Skills
8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years experience in the field of cell therapies preferred.
Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs.
Ability to operate in a Controlled/Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.
Demonstrated ability to manage multiple complex relationships within a CMO network.
Experience with electronic Quality Management Systems.
Experience in conducting or hosting Quality and/or Health Authority audits.
Excellent interpersonal, verbal and written communication skills.
Ability to function efficiently and independently in a changing environment.
Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills.
Strategic thinking and high emotional intelligence.
Manage and advance multiple projects simultaneously and dynamically reprioritize as needed.
Demonstrated capacity to think creatively when addressing complex situations.
Education
Degree (Bachelor’s or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology.
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Title: Quality Assurance Manager
Company: Aequor
Location: Waltham, Massachusetts, USA
Category: Healthcare, Quality Assurance – QA/QC
