Quality Coordinator

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.

Prepares and distributes required documentation for requested production work orders.

Perform documentation and records review of completed orders to ensure compliance with cGMP’s and

customer requirements.

Creating and updating batch records, forms and material specifications as well as organizing internal and

customer approval of batch records and specifications.

Performs and submits batch records, accountability reports and necessary documentation to customers to

facilitate product release.

Help identify, communicate, track and resolve document related issues with other departments and

customers.

Function as one of the customer points for comments or questions pertaining to batch documentation.

Assist with providing quality related metrics.

Performs finished product batch release of approved production lots.

Meet with management to address issues or concerns with the batch documentation.

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 recordsand specifications.

This position may require overtime and/or weekend work.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Attendance to work is an essential function of this position

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.#LI-DT1Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)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.Why work for PCI Pharma Services?At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled