Sr. Specialist, Quality Assurance
1 Hampshire Street Cambridge, MA 02139 US
(Target PR: 42-75/hr)
*Depending on experience
Seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA.
The individual in this role will be part of a cohesive team responsible for supporting cGMP small molecules produced internally. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early-stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.
Here’s What You’ll Do:
Provide on-the-floor Quality support to manufacturing, review documentation, and make quality decisions and/or escalate issues to management that may impact operations.
Participate in quality oversight of manufacturing through real-time observations of activities.
Participate in quality focused teams across broad ecosystem of functions.
Authors and reviews SOPs, policies, and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
Oversee and review batch record documentation.
Review/Approve manufacturing deviations, change controls and CAPAs.
Closely partner with peers for disposition of Small Molecules.
Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Monitor process operations to ensure compliance with specifications.
Practice safe work habits and adhere to safety procedures and guidelines.
Utilize knowledge to improve operational efficiency.
Here’s What You’ll Bring to the Table:
A minimum of 5 years’ experience in a GMP manufacturing environment with a bachelor’s degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry or related field or seven years of experience in a clinical quality assurance environment.
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