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.
Summary of Objective:
The Quality Coordinator role is responsible for providing the generation, review and traffic of production batch records and orders within a cGMP environment. This position ensures that operational goals and objectives of the team are accomplished within prescribed time frames and helps drive project success to provide PCI a competitive advantage in long-term quality customer management.
Essential Duties and Responsibilities:
* Prepares and distributes required documentation for requested production work orders. * Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements. * Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications. * Prepares customer required samples for shipment according to approved shipping instructions. * Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. * Organize internal and customer approval of batch records and specs. * Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements. * Perform Line Clearance inspections of equipment and production suites. * 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 records. * Initiating supplier non-conformance reports and effectuates material control. * Reviews and integrates planned deviation requests into batch records when needed. * Adherence to PCI and cGMP policies, procedures, rules and regulations. * Attendance to work is an essential function of this job. * May perform label creation duties including generating computerized labels. * May perform duties of Quality Auditor as assigned by Supervisor/Manager Required: *
Qualifications:
Required:
EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED
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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.