Clinical QA Specialist Quality Operation
Moderna Therapeutics

Job Order #: 17571443

Cambridge, MA 02141

Full Time

40 hours per week

POSTED 8/27/2022

EXPIRES 11/24/2022

Job Description

The Role:

Moderna is seeking a Specialist of Clinical Quality Assurance Quality Operations responsible for real time on the floor quality oversight of clinical manufacturing and lot disposition at Moderna Inc. This position will be based on our Clinical Manufacturing sites at Burlington and Norwood, MA.

The individual in this role will be part of a cohesive team responsible for supporting Clinical cGMP cell bank, plasmid, mRNA drug substance and mRNA drug products produced at Moderna. They will provide real time 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 and commercial products. Strong decision-making skills and independent thinking will be paramount for candidate success. They will interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Manufacturing, Quality Control, Logistical and Process Development Technology Transfer counterparts.

The shift is 2nd shift from 4:00PM to 2:00AM Wednesday - Saturday

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.

* Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.

* Participate in quality oversight of manufacturing through real-time observations of activities.

* Monitor process operations to ensure compliance with specifications.

* Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.

* Identifying risks and communicating gaps for quality and GMP process/systems

* 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.

* Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations.

* Oversee and review executed electronic and paper batch record documentation.

* Support quality functional groups on as needed basis.

* Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.

* Perform lot disposition of Cell Bank, Plasmid, Drug Substance and Drug Product

* Practice safe work habits and adhere to Moderna's 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.

* Experience providing QA support and oversight to manufacturing operations

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

* Highly competitive and inclusive medi
To view the full job description please use the link below.

How To Apply


320 Bent St.
Cambridge, MA 02141

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Karen Shih


Talent Acquisition Coordinator





320 Bent St.
Cambridge, MA 02141