- Lead Quality improvement projects.
- Work closely with FDBT and Customer Project Managers to assure QC and QA deliverables and timelines are managed and met.
- Participate in project team / client meetings as needed.
- Assist Quality staff in managing and closing out Deviations / CAPAs / Change Controls.
- Work with Quality management in coordinating testing and on-time reporting results for all projects.
- Work closely with Quality Assurance and Document Control to ensure QC and QA documentation is ready for finalization: Prepare Document Change Requests (DCR’s) for routing and approval to include: Product specifications / SOPs / Protocols / Reports.
- Coordinate and manage external testing: Obtain quotes, submit purchase requests: Prepare sample submission package to external lab and track testing.
- Prepare final product data package and draft CoA.
- Assist in Blue Mountain equipment entry for relevant equipment.
- All other duties as assigned.
Required Skills & Abilities:
- Manage QC testing timelines and project deliverables.
- Ability to multi-task and prioritize work assignments with little supervision.
- Must have excellent organizational, written communication and oral communication skills.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Ability to accurately complete required documentation.
- Knowledge of MS Office (Word, Excel, Powerpoint, Project).
- Excellent attention to detail.
- Ability to work in a team or independent setting and collaborate with employees from various departments.
- Computer proficiency required.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Ability to work weekends and off-shift hours as needed to support QC deadlines.
- Attendance is mandatory.
- Bachelor degree in a scientific discipline , with 3 years of experience with cGMP
- Associate degree in a scientific filed or Certificate in Biotechnology with 5 years of experience with cGMP
- PMP certified
- GMP/GLP experience