What are the responsibilities and job description for the Sr. QA Associate I position at PCI Pharma Services?
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.
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.
Job Details
We are currently seeking a Sr QA Associate 1 who is the Quality Subject Matter Expert whom ensures manufacturing areas are maintained and in strict compliance. The associate independently reviews and approves lot file documentation, identifies/assesses regulatory and quality risks in manufacturing activities and processes, and independently investigates, troubleshoots, and rectifies issues as a result of QA analysis to drive process improvements and enhancements. The QA associate also leads projects, trains junior staff, and provides quality expertise and guidance to operational staff.
Responsibilities
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.
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.
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.
Job Details
We are currently seeking a Sr QA Associate 1 who is the Quality Subject Matter Expert whom ensures manufacturing areas are maintained and in strict compliance. The associate independently reviews and approves lot file documentation, identifies/assesses regulatory and quality risks in manufacturing activities and processes, and independently investigates, troubleshoots, and rectifies issues as a result of QA analysis to drive process improvements and enhancements. The QA associate also leads projects, trains junior staff, and provides quality expertise and guidance to operational staff.
Responsibilities
- Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
- Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices.
- Independently performs quality operations within multiple manufacturing departments
- Participates in multiple process improvement projects
- Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
- Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
- Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
- Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
- Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes.
- Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies PCI’s cultural values and aligns daily actions with department goals and company culture.
- Bachelor’s degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering or equivalent required
- Minimum of 2-5 years of relevant engineering experience required, cGMP experience preferred
- Experience with QMS, reviewing documents, managing change controls
- Hands-on experience with Process Mechanical Systems including facilities and utility equipment
- Understanding of plant and equipment reliability preferred
- Experience with CAD software preferred
- Understanding of pharmaceutical systems, processes and utilities for aseptic processing
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.
Salary : $41 - $46
