When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Work Hours: This is a full-time, exempt position (40 hrs/week). Days and hours of work are Monday through Friday; 8:00 a.m. to 5:00 p.m. with a 1 hour lunch. Occasional overtime for evening and weekend work may be required as job duties demand.
How will you make an impact?
The Compliance Specialist II role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of manufacturing. The Specialist II uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support equipment, documentation, investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
What will you do?
- Support change controls, corrective and preventative actions and internal and external observations.
- Lead investigations if needed.
- Utilizes process knowledge and investigational skills to identify and resolve issues and drive continuous improvement in process operations.
- Performs training with staff for Deviations, Change Controls, and CAPAs as needed.
- Works cooperatively with others to meet group and organizational goals.
- Supports cross-functional continuous improvement teams, with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology.
- Supports cross-functional company goals for Site Metrics.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Participate in client and planning meetings as requested.
How will you get here?
- High School Diploma/GED required; Bachelors Degree highly desired.
- Minimum of 2 years' experience in cGMP pharmaceuticals or biologics manufacturing and/or quality.
- Manufacturing experience required.
- Thorough knowledge of cGMPs.
- Solid understanding of applicable regulatory requirements.
- Strong working knowledge of Microsoft Office.
- Ability to deliver high quality documentation paying attention to detail.
- Strong interpersonal and communications skills; written and oral.
- Demonstrated ability to motivate exempt and non-exempt employees and demonstrated management skills, (i.e., business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution).
- The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
Preferred skills and experience:
- CMDO experience preferred.
- Cleanroom experience preferred.
- Experience using SAP preferred.
- Autoclave experience preferred.
- Buffer or media preparation experience preferred.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
To Apply, please click the following link: https://thermofisher.contacthr.com/82218378
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