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.
1.Prepares and distributes required documentation for requested production work orders. 2. Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer requirements. 3. Creating and updating batch records, forms and material specifications as well as organizing internal and customer approval of batch records and specifications. 4. Performs and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. 5. Help identify, communicate, track and resolve document related issues with other departments and customers. 6. Function as one of the customer points for comments or questions pertaining to batch documentation. 7. Assist with providing quality related metrics. 8. Performs finished product batch release of approved production lots. 9. Meet with management to address issues or concerns with the batch documentation. 10. Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications. Organize internal and customer approval of batch records and specifications. 11. This position may require overtime and/or weekend work. 12. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. 13. Attendance to work is an essential function of this position 14. 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.
