- 4+ years of experience in the pharmaceutical/biotech industry
- Demonstrated aptitude or ability to learn to gain a strong understanding of GMP/GLP/GCP regulations
salary: $45 - $50 per hour
shift: First
work hours: 6 AM - 6 PM
education: Bachelors
Responsibilities
- Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs etc.
- Support quality decisions that may impact operations, ensuring appropriate escalation.
- Identify risks and communicate gaps for quality and GMP process/systems.
- Reviews and approves facility alarms, facility work order requests, and return-to-service documentation.
- Support, reviews and approves Deviations and CAPAs
- Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
- Collaborate with Manufacturing to resolve equipment and process issues
- Support internal audits.
- Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
- 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.
The essential functions of this role include:
Skills
Qualifications
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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).
Applications accepted on ongoing basis until filled.