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6 Month Contract with possible renewal
Moderna is seeking a (Contract) Specialist of Quality Assurance Batch Disposition reporting to the Associate Director of External Quality Assurance, Batch Disposition. The individual in this role will be responsible for providing Quality support in batch disposition for commercial products manufactured at CMOs. This position will be 1st shift from 8:00 am to 6:00 pm working Wednesday through Saturday.
Here's What You’ll Do:
Perform all activities required for batch disposition of Drug Substance and Drug Product manufactured by the CMO
Assess change controls for regulatory market restrictions
Prepare GMP documentation required for market release
Closely partner with peers for disposition of Drug Substance and Drug Product to ensure rapid disposition of commercial products
Participate in quality focused teams across Moderna’s broad ecosystem of functions
Authors and reviews SOPs and policies to ensure compliance and adherence to regulations and cGMP operations
Work closely with team members to recognize opportunities for improvement and help drive change
Support Annual Product Review report generation and approval, as needed
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:
BS with at least 4 years of experience, or a Master’s level degree and 2 years’ experience in the pharmaceutical/biotech industry
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Working knowledge of batch release processes and activities (assessment of batch data, quality events, change controls, etc.) for Drug Substance and/or Drug Product preferred
Experience with Excellent judgment and ability to communicate complex issues in an understandable way.
Outstanding communication skills (verbal and written).
Knowledge of late-stage pharmaceutical development and validation principles a plus.
Ability to manage multiple projects in a fast-paced environment, project management experience a plus.
Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
Travel up to 10%.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.