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.
Excited to grow your career? We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply! Our people make all the difference in our success.
Job Description
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.
Please note that you must be in your current position for a minimum of 6 months and in good standing to be eligible to apply for other internal positions.
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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.
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
