Specialist, MS&T – Investigations

The Role

In this role, you will exercise with limited supervision, discretion and applies knowledge of cGMP regulations and biopharmaceutical production processes to oversee the execution of thorough investigation and root cause analyses of quality events to ensure corrective and preventative actions are identified. Intermittently, work will be conducted within a cleanroom environment and typically involves limited physical activity, lifting and standing for periods of time.  

Here’s What You’ll Do

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

• Practice and promote safe work habits and adheres to safety procedures and guidelines.

• 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 of gowning and vision, if applicable. 

• Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS.

• Utilize manufacturing process knowledge and investigational skills applying techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe, to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events.

• Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)

• Conduct document revisions and/or document management including batch production records and manufacturing procedures.

• Generate investigative test plans and reports, as required.

• No approval or delegation authority associated with this role.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Basic Qualifications)

• STEM degree with 3-5 years’ industry experience or a Masters’ degree with 1-2 years’ industry experience

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• 0-2 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment.  Comprehensive understanding of GMP regulations.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna provides employees with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental, and vision coverage options

• Dedicated guided healthcare coordination through Included Health that elevates healthcare planning for every kind of employee, including our LGBTQ+ employees and other underserved communities

• Flexible Spending Accounts for medical expenses and dependent care expenses

• Lifestyle Spending Account to help you engage in personal enrichment and self-care activities

• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

• Family care benefits, including subsidized backup care options and on-demand tutoring

• Adoption, surrogacy, and family-planning benefits

• Paid time off, including:
  •    Vacation, sick time, and observed Company-wide holidays
  •    Paid volunteer time to participate within your community
  •    Discretionary year-end shut down 
  •    Paid 4-week sabbatical after 5 years, and every 3 years thereafter

• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

• Generous 401k match and Financial Planning supports

• Moderna-paid Life, LTD, and STD insurance, as well as voluntary benefit options

• Concierge service including home services research, travel booking, and entertainment requests