PCI Services Bedford , NH 03110
Posted 7 days ago
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 SUMMARY
The Quality Associate I - Operations is responsible to provide QA support real-time for GMP Manufacturing of drug product. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other 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.
JOB DUTIES
Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance
Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product
Act as first responder for on the floor quality issues in a timely manner, documentation of all
events/investigations and required immediate corrective actions
May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management
Perform Acceptable Quality Limit (AQL) visual inspection of drug product
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
Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
PROFESSIONAL SKILLS
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
EXPERIENCE
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
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferred
EDUCATION
pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role
supporting late stage clinical and/or commercial production preferred
QUALITIES
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
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
Frequent reading, writing, and verbal communication
Must be able to travel between multiple local production facilities
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
COMMUNICATIONS & CONTACTS
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
TRAVEL < 10%
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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, 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.
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