QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 330pm-2am)
- Compensation
- Not disclosed
- Location
- Bedford, NH, USA
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Qa
- Posted
Skills
Must have
- Bachelor’s Degree in a relevant scientific field.
- Minimum 2 years’ experience in relevant GMP industry preferred.
- Equivalent combination of experience and education may be considered.
- Exposure to RCA, technical writing, and working with quality related investigations.
- Exposure to lean operation excellence highly desirable
- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working
- with international regulations such as ICH
- Knowledge and ability to apply basic scientific principles to solve operational, as well as routine
Nice to have
- ASQ certification is referred.
- Strong organizational skills and attention to detail
- Ability to make risk-based decisions and resolve issues with minimal guidance.
- Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing.
- Proficiency in MS Office including Word, and Excel
- Ability to work in a dynamic, fast-paced work environment.
- Honesty, integrity, respect and courtesy with all colleagues
- Able to work with some limited supervision, able to escalate issues as needed.
- Is flexible and adaptable through operational and organizational change.
Full description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The QA Operations Specialist I – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The QA Operations Specialist I – Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.
Essential Duties and Responsibilities:
- Perform QA on-the-floor activities supporting client projects, including room release, auditing
- critical processes, reviewing GMP documentation in real time.
- Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to
- policies and procedures.
- Batch record review for adherence to internal procedures and Good Documentation Practices
- Support the evaluation and disposition of intermediates, finish bulk drug substance and drug
- product.
- Review, approval and disposition of incoming materials such as consumables, excipients, and
- Active Pharmaceutical Ingredient.
- QA review and approval of new and revised GMP documents such as SOP’s and raw material