QA Specialist II Operations

LSNE - MADISON, LLC • Madison, WI • 7h ago

JOB REQUIREMENTS: 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,... For
full info follow application link. LSNE is an EEO/AA Employer and all
qualified applicants will receive consideration for employment without
regard to, their race, color, religion, sex, age, national origin,
ancestry, sexual orientation, gender identity, disability, protected
genetic information, protected veteran status, military service, or
other protected status. The Company\'s EEO policy, as well as its
affirmative action obligations, include the full and complete support of
The Company. *** APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/69F8162CC53246CE

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