QA ASSOCIATE I - OPS

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.

Summary of Objective:

The Quality Associate I - Operations is the first of two levels within the QA Associate job family The associate I provides real-time QA support on the floor for GMP Manufacturing of drug product. The work scope includes 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.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Perform 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
• 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.

• 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
• Demonstrated capacity to work on multiple projects (duties) simultaneously

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Cross functional staff, members of management, internal and external clients, members of the Quality organization

• < 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
• Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 0-2 years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production preferred
• 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

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.