Reporting to the Manager of QC Sample Management, the Quality Control Supervisor will be responsible for leading part of QC Sample Management team. The individual in this role will supervise a growing team responsible for cGMP Sample coordination including cross functional collaboration with internal and external labs, as well as contribute to hands-on laboratory work. This position will be 1st shift, working 7:00 am to 3:00 pm, Monday through Friday.
Here's What You'll Do:
Lead a team of associates responsible for sample management activities for QC Chemistry, Microbiology, Bioassay, Raw Materials from CMOs and various Development labs
Oversee progress of daily schedule to ensure safe and timely completion of sample processing and quality records
Author/revise SOPs, protocols, quality systems records such as deviations, CAPAs, change control
Create weekly sample management schedules and run weekly team meetings
Oversee the hiring, development, retention, and performance evaluation of QC Sample Management Associates, including routine 1:1s
Participate in and partner with the Digital team to expand and optimize the use of LIMS (LabVantage) system
Work with the Quality Control teams to continuously improve the quality, compliance, and efficiency of QC operations
Provide support to audit teams for internal and external audits
Controlled temperature unit (CTU) management, maintenance and troubleshooting
Lead troubleshooting and provide guidance and support to the sample management team for compliance issues
Train and oversee the teams' training assignment and ensure compliance requirements remain current
Establish and maintain a safe laboratory working environment
Here's What You'll Bring to the Table:
BA/BS in a relevant scientific discipline with a minimum of 5-8 years (or MS in a relevant scientific discipline with a minimum of 2-5 years) Quality Control experience in a cGMP organization
Demonstrate ability to effectively and independently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment
Detailed knowledge of LIMS system (LIMS) and quality document system (Veeva)
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
Experience with gowning, aseptic technique and general lab safety practices
Flexible schedule to support periodic on call, weekend or holiday coverage
Strong and effective people management skills
Here's What We'll Bring to the Table:
On-site subsidized cafeteria or catered lunches
Free parking, monthly subway pass or a subsidized commuter rail pass
Free annual corporate membership to Bluebikes
Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
Flexible Spending Accounts for medical expenses and dependent care expenses
16 weeks of 100% paid parental leave for all new parents
16 weeks 100% paid family caregiver leave
20 weeks 100% paid medical leave
Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
Adoption assistance and discounts to local childcare centers, as well as access to care.com
401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
Voluntary legal assistance plan
15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six 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.