QA Specialist II - Operations

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 Specialist II will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality System review.  This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs.  In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products.

Essential Duties and Responsibilities:

• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
• Review and approve master batch records for the timely initiation of GxP manufacturing activities
• Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
• Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
• Provide direction for complex investigations and CAPAs
• Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
• Review, develop, and improve quality system procedures, specifications, and test methods
• Review and approve CAPAs to prevent recurrence of deviations
• Review and approve Change Control documentation
• Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process
• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
• Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
• Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
• Coordinate change control review meetings
• Monitor status of change controls and facilitate the approval process
• Perform risk assessments to comply with internal procedures and external guidelines
• Provide training on department specific procedures and systems
• Interface with clients to address any documentation and compliance concerns
• Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
• Ensures site readiness for regulatory inspections

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.

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, Excel, Access and Visio
• Excellent verbal and written communication skills required

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

• This position may require long periods at a desk, other times are at meetings or in manufacturing 
• 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

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.

EDUCATION

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
• ASQ certification preferred

EXPERIENCE

• Experience performing RCA, technical writing, and working with quality related investigations
• Knowledge of laboratory and production equipment and IQ/OQ/PQ
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

#LL-LLi

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.