Sr. Specialist, QA for QC Job at Moderna Therapeutics
The Role:
Moderna is seeking a Quality Assurance Specialist for a position based at their Norwood, MA manufacturing site and will directly support the growing Personalized Medicine Program. The main responsibility for this position is to provide quality oversight of Quality Control and Facilities, with a focus on deviations, change controls, and CAPAs. The individual will work closely with Manufacturing, Quality Control, and Facility teams.
Here’s What You’ll Do:
Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations.
Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
Works closely with others to determine root cause and potential preventative/correction actions.
Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
Ensure timely closure of investigation.
Participates in quality oversight of Quality Control and Facilities.
Reviews and approves facility alarms, facility work requests, and return-to-service documentation.
Reviews and approves QC method qualification protocols and reports.
Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
Participate in internal audits for compliance with SOPs, GMPs, and regulations.
Other activities as deemed necessary e.g. logbook reviews
Here’s What You’ll Bring to the Table:
6+ years of experience in a GMP manufacturing environment, preferably within Quality, with a Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
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:
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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
Moderna is seeking a Quality Assurance Specialist for a position based at their Norwood, MA manufacturing site and will directly support the growing Personalized Medicine Program. The main responsibility for this position is to provide quality oversight of Quality Control and Facilities, with a focus on deviations, change controls, and CAPAs. The individual will work closely with Manufacturing, Quality Control, and Facility teams.
Here’s What You’ll Do:
Identifies, classifies, and reports deviations, as appropriate, and typically works on more complex minor and/or major deviations.
Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying that changes adhere to SOPs and regulatory compliance.
Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
Works closely with others to determine root cause and potential preventative/correction actions.
Authors and reviews SOPs and policies. Create and establish process and procedures to ensure compliance and adherence to regulations and cGMP operations.
Ensure timely closure of investigation.
Participates in quality oversight of Quality Control and Facilities.
Reviews and approves facility alarms, facility work requests, and return-to-service documentation.
Reviews and approves QC method qualification protocols and reports.
Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems.
Participate in internal audits for compliance with SOPs, GMPs, and regulations.
Other activities as deemed necessary e.g. logbook reviews
Here’s What You’ll Bring to the Table:
6+ years of experience in a GMP manufacturing environment, preferably within Quality, with a Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
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
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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
-
Please Note :
ajayjain.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, ajayjain.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.