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À propos
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.
JOB DESCRIPTION:
Position Title
: QA Operations Specialist I - Floor Support
Location:
Bedford, New Hampshire
Department:
Quality Assurance,
Reporting To:
QA Supervisor,
Responsible For (Staff):
No
The
QA Operations Specialist I - Floor Support
is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial medical device products in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and fill processes, GMP documentation and Batch Record review, line clearance, 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 Medical device 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
Review, approval and disposition of incoming materials such as consumables, excipients, and bulk device Ingredient, as applicable.
QA review and approval of new and revised GMP documents such as SOP's and raw material specifications.
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
Assist in nonconforming material investigations.
Review of Quality Control Environmental Data
Review and approval of work orders impacting manufacturing facilities and utilities
May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
Advise and coach internal customers on proper documentation of tasks
Assist in the initiation of Quality Systems (deviations, CAPA, Nonconformances).
Support Visual Inspection, packaging, and labeling operations
Create, review, and approve final product labels
Participate in SOP revision as it pertains to process improvements.
Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
QUALIFICATIONS:
Required:
Exposure to RCA, technical writing, and working with quality related investigations.
Bachelor's Degree in a relevant scientific field is preferred.
Minimum 2 years' experience in relevant GMP industry preferred.
An equivalent combination of experience and education may be considered
Exposure to lean operation excellence highly desirable
Knowledge of FDA regulations (i.e., 21CFR Part 820)
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, PHA, etc.)
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.
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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (https://pci.com/)
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.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
Compétences linguistiques
- English
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