at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
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.
Creates, updates and peer reviews Master Packaging Instructions, forms, and material specifications to ensure that the documents meet internal and customer requirements, as well as obtaining internal and customer approvals of Master Packaging Instructions and specifications.
Assist with performing batch record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements.
Assist with creating and/or reviewing batch records to support the business. Primary Quality Assurance contact for assigned customer accounts.
Assist as company liaison with customers concerning quality control documentation.
Help identify, communicate, track, and resolve document-related issues with other departments and customers.
Attend or facilitate conference calls and customer meetings to provide or obtain quality-related information and customer-specific metrics.
Assist with populating quality-related metrics and key performance indicators for the team's performance.
Assist with initiating and investigating quality deviations with the responsible functional area.
Initiating and completing supplier non-conformance reports and effectuating material control.
Assist with training, developing, and mentoring new Quality Coordinators.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
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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.
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.
