QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 3:30pm-2am)

QUALIFICATIONS:

• Required:
• 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 quality tasks.
• Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred.
• Scientific, technical, and mechanical subject matter comprehension and aptitude
• Able to articulate scientific and technical subject matter
• Preferred:
• 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.
• #LI-RS1
• Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
• Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
• At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.