Job Summary
In this role, you will be responsible for providing quality assurance network support for contract manufacturing and testing. You are responsible for ensuring that all batch-related activities, including receipt, review, and release of Bulk Drug Substance (BDS) and Drug Product (DP), are conducted in compliance with regulatory standards. This role is focused on executing Batch Record Release activities following Drug Product CMO Release and authorization for shipment to Third Party Distribution Network and further disposition activities. The role requires a detail-oriented individual with strong quality assurance and regulatory knowledge, capable of making critical decisions that impact product quality and patient safety.
location: Telecommute
job type: Contract
salary: $48 - 58 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Job Responsibilities
- Provide network quality assurance support across the Moderna CMO Drug Product QA teams, with a focus on process efficiency and quality.
- Perform GMP Confirmation (Release activity) for Drug Product CMO batches, including batch record review, eQMS documentation checks and SAP release steps.
- Prepare and review documentation for Quarantine Shipment process.
- Provide administration and Veeva eQMS documentation support for archival
- 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.
- Additional duties as may be assigned from time to time
qualifications:
Required
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.
- 5+ years of experience in Quality Assurance roles within the pharmaceutical or biotechnology industries
- 5+ years of experience with batch oversight and CMO management.
- Demonstrated experience with batch record review, batch release and/or disposition activities.
- Training in Veeva Quality Management System and SAP or similar quality document management system.
- Proficiency in regulatory requirements.
- Familiarity in Drug Product GMP Manufacturing
- Effective communication skills, both written and verbal.
- Ability to work cross-functionally and collaborate with internal and external stakeholders.
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
