Job Information
PCI Pharma Services QA Specialist I - Floor Support (Sun-Wed 6:30 AM - 5PM) in Bedford, New Hampshire
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.
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 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 and utility monitoring data and test results
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).
Perform Acceptable Quality Limit (AQL) visual inspection of final drug product
Support Visual Inspection, packaging, and labeling operations
Create, review, and approve final product labels
Perform inspection of final product retains
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
Special Demands: 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Ability to work in a dynamic, fast paced work environment
Honesty, integrity, respect, and courtesy with all colleagues
Creative with the ability to work with minimal supervision and balanced with independent thinking
Resilient through operational and organizational change
Exceptional organizational skills and attention to detail
Ability to make risk-based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, and Excel
Excellent verbal and written communication skills required
Work Environment
Ability to don cleanroom garments and pass aseptic gowning qualification.
Frequent reading, writing, and verbal communication
Must be able to travel between multiple local production facilities (within a mile of each other)
Able to translate ideas to actual concepts and processes
Proven ability to manage multiple projects (duties) simultaneously
Able to work in a highly complex environment with competing demands and priorities
Cross functional staff, members of management, internal and external clients, members of the Quality organization
No managerial responsibilities. This is an individual contributor role.
< 10% Travel
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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
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.
ASQ certification preferred.
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, Diversity, Equity, and Inclusion (DEI) 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