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.
Responsibilities
* Creating and building electronic batch records templates by design or by translating existing paper records into the eBR MasterControl system.
* Ensuring all records meet GMP regulations and accurately reflect all production activities, including materials usage, process parameters, and testing/ inspection results.
* Support on the integration of electronic batch records with other equipment and software, such as JDE and EM system.
* Revising and updating EBRs, standard operating procedures (SOPs), bills of materials (BOMs), Work instructions (WI) as needed.
* Managing and implementing MOCs related to the eBR system.
* Training users on eBR processes and best practices and providing support to production team.
* Working with various departments, including quality assurance, manufacturing, and subject matter experts, to gather input and ensure the eBRs meet operational needs.
Required Skills And Qualifications
* Strong understanding of GMP and other relevant regulatory guidelines.
* Proficiency with computer systems and software, especially EBR or manufacturing execution systems (MES).
* Experience collaborating in cross-functional teams across production, quality, Engineering and IT.
* Excellent communication skills, both verbal and written.
* Ability to work independently and as part of a team.
* Experience with document review or a manufacturing environment is desirable.
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, Equity and Inclusion 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.