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 organizationReview and approve master batch records for the timely initiation of GxP manufacturing activitiesResponsible for quality oversight and administration of the deviation/investigation and CAPA programsReview and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP complianceProvide direction for complex investigations and CAPAsEnsure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAsReview, develop, and improve quality system procedures, specifications, and test methodsReview and approve CAPAs to prevent recurrence of deviationsReview and approve Change Control documentationResponsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review processEstablish 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 managementServe as QA representative to cross functional project teams such as tech transfer, process validation, and process improvementPerform 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 organizationCoordinate change control review meetingsMonitor status of change controls and facilitate the approval processPerform risk assessments to comply with internal procedures and external guidelinesProvide training on department specific procedures and systemsInterface with clients to address any documentation and compliance concernsInitiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicableEnsures site readiness for regulatory inspections

PROFESSIONAL SKILLS

Exceptional organizational skills and attention to detailAbility to make risk based decisions and resolve issues with minimal guidanceExcellent interpersonal skills and the ability to communicate well orally and in writingProficiency in MS Office including Word, Excel, Access and VisioExcellent verbal and written communication skills required

QUALITIES

Ability to work in a dynamic, fast paced work environmentHonesty, integrity, respect and courtesy with all colleagues Creative with the ability to work with minimal supervision and balanced with independent thinkingResilient 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 communicationMust be able to travel between multiple local production facilitiesAble to translate ideas to actual concepts and processesProven ability to manage multiple projects (duties) simultaneouslyAble 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 productionASQ certification preferred

EXPERIENCE

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

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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.