WI3636101

1

Bachelor's Degree

Bachelors Degree

Unspecified

40

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 Manager is
responsible for oversight of all daily functions of the quality system.
Directly Supervise Documentation Control, QA Associates and Trainer, and
act as backup and support to their activities. 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. Work directly with the Sr. Director, Quality on continuous
improvement activities. Responsible for ensuring that client
specifications are met during materials receipt, Drug / Device
processing and final product shipment. Responsible for ensuring that
procedures are followed and quality standards are met. Works directly
with the Sr VP of Quality to evaluate products and materials for
compliance to specifications. Oversight for established quality systems
(Document Control, CAPA, Deviation, Environmental Monitoring, Change
Control, Complaint, Calibration, Documentation, Training, Component
Control, Batch Record Review, Label Control, Product Release).
Review/approval of Validation Protocols (master and final reports).
Approval of Deviations and CAPAs. Responsible for Environmental
Monitoring and WaterTrend Reports. Provide QA Staff support (and backup)
including: Scheduling updates and assignment of duties. Documentation
Control prioritization: document processing, batch record issuance,
change control issuance. Training: issuing notifications for training
needs, maintenance of training files, initiating core training for new
employees, present training to personnel as needed. Operations: provide
line clearances and documentation as needed. Product and Materials
Records Review: batch record review and release, materials review and
approval, including - calibration, water testing, environmental
monitoring, temperature and humidity review. Work Environment: Work is
primarily performed at a desk and/or in an office environment. for 1/2
to 3/4 of the day. Qualifications: The requirements listed below are
representative of the knowledge, skill, and/or ability required\... 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/A098BA3EEAAF454B