Specialist, Quality Assurance

7 days ago

Norwood, United States Moderna Full time

**The Role**:
The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc.

**Here’s What You’ll Do**:
Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or escalates issues to management that may impact operations.

Performs QA review of master batch records and electronic batch records

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 oversite 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.

Support quality functional groups on as needed basis.

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

Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.

Utilize knowledge to improve operational efficiency.

Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Here’s What You’ll Bring to the Table

**Education**: Minimum Bachelor’s degree in a scientific/engineering discipline or equivalent experience.

**Experience**: 5 years of experience in a GMP manufacturing environment or 3 years of experience with a Bachelor's degree.

Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).

This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community

**Generous paid time off, including**:

- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an

  • Specialist, Quality Assurance

    2 months ago

    Norwood, United States Randstad North America, Inc. Full time

    As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a la Quality Assurance, Specialist, Quality, Assurance, Technology, Staffing, Manufacturing

  • specialist, quality assurance

    1 month ago

    norwood, United States Randstad US Full time

    specialist, quality assurance. + norwood , massachusetts + posted 5 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48067 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...

  • specialist, quality assurance

    1 month ago

    norwood, United States Randstad US Full time

    specialist, quality assurance. + norwood , massachusetts + posted 3 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48121 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...

  • specialist, quality assurance

    1 month ago

    norwood, United States Randstad US Full time

    specialist, quality assurance. + norwood , massachusetts + posted 3 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48123 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...

  • specialist, quality assurance

    1 month ago

    norwood, United States Randstad US Full time

    specialist, quality assurance. + norwood , massachusetts + posted 3 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48122 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...

  • specialist, quality assurance

    4 weeks ago

    norwood, United States Randstad US Full time

    specialist, quality assurance. + norwood , massachusetts + posted 3 days ago **job details** summary + $40 - $50.97 per hour + contract + bachelor degree + category life, physical, and social science occupations + reference48123 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you...

  • specialist, quality assurance

    2 weeks ago

    Norwood, Massachusetts, United States Randstad Full time

    specialist, quality assurance. norwood , massachusetts posted 5 days ago job details summary $40 - $50.97 per hour contract bachelor degree category life, physical, and social science occupations reference48123 job details job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you...

  • Specialist, Quality Assurance

    4 weeks ago

    Norwood, Massachusetts, United States randstad us Full time

    specialist, quality assurance. norwood, massachusetts posted may 15, 2024 job details summary $40 - $50.97 per hour contract bachelor degree category life, physical, and social science occupations reference48122 job details job summary As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role...

  • Specialist, Quality Assurance

    4 weeks ago

    Norwood, United States randstad us Remote Work Freelance Full time

    specialist, quality assurance. norwood, massachusetts posted may 15, 2024 job details summary $40 - $50.97 per hour contract bachelor degree category life, physical, and social science occupations reference48122 job details job summary As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role...

  • Sr. Quality Assurance Specialist

    1 week ago

    Norwood, United States Randstad Life Sciences US Full time

    6 Month Contract Norwood, MA (open to hybrid schedule after training) PR: $45-55/hour Job Summary The Quality Assurance Sr. Specialist is based in Norwood, MA. This position is part of Moderna's Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide...

  • Sr. Quality Assurance Specialist

    2 weeks ago

    Norwood, United States Randstad Life Sciences US Full time

    6 Month ContractNorwood, MA (open to hybrid schedule after training)PR: $45-55/hour Job SummaryThe Quality Assurance Sr. Specialist is based in Norwood, MA. This position is part of Moderna’s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide...

  • Sr. Quality Assurance Specialist

    2 weeks ago

    Norwood, United States Randstad Life Sciences US Full time

    6 Month ContractNorwood, MA (open to hybrid schedule after training)PR: $45-55/hour Job SummaryThe Quality Assurance Sr. Specialist is based in Norwood, MA. This position is part of Moderna’s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to provide...

  • Quality Assurance Specialist

    4 weeks ago

    Norwood, Massachusetts, United States Randstad USA Full time

    The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced at this facility. 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 Assurance Specialist

    1 month ago

    Norwood, Massachusetts, United States Randstad USA Full time

    The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced at this facility. 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...

  • Specialist, Quality Assurance

    4 weeks ago

    Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc.Heres What Youll Do: Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or escalates issues to management that may impact operations. Performs QA review of master batch...

  • Specialist, Quality Assurance

    4 weeks ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc.Heres What Youll Do:Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or escalates issues to management that may impact operations.Performs QA review of master batch records...

  • Specialist, Quality Assurance

    4 weeks ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Quality Assurance Specialist is part of a cohesive team responsible for supporting cGMP oversight of internal manufacturing at Moderna Inc.Heres What Youll Do:Provides on-the-floor Quality support to Manufacturing. Makes quality decisions and/or escalates issues to management that may impact operations.Performs QA review of master batch records...

  • Sr. Specialist Quality Assurance

    8 hours ago

    Norwood, United States Connexion Systems & Engineering, Inc. Full time

    Job DescriptionJob DescriptionConnexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.Sr. Specialist Quality AssuranceWe are really looking for people who have more quality...

  • Quality Assurance Specialist

    1 month ago

    Norwood, Massachusetts, United States Randstad USA Full time

    The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced at this facility. 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 Assurance Specialist

    4 weeks ago

    Norwood, Massachusetts, United States Randstad USA Full time

    The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced at this facility. 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...