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:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following:
1. Prepares and distributes required documentation for requested production work orders.
2. Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements.
3. Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications.
4. Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
5. Organize internal and customer approval of batch records and specs.
6. Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements.
7. Perform Line Clearance inspections of equipment and production suites.
8. Help identify, communicate, track and resolve document related issues with other departments and customers.
9. Function as one of the customer points for comments or questions pertaining to batch records.
10. Initiating supplier non-conformance reports and effectuates material control.
11. Prepares planned deviation requests when needed.
12. Adherence to PCI and cGMP policies, procedures, rules and regulations.
13. May prepare customer required samples for shipment according to approved shipping instructions.
14. Attendance to work is an essential function of this job.
15. May perform label creation duties including generating computerized labels.
16. May perform Quality Auditor duties as assigned by Supervisor/Manager.
17. Other duties as assigned by Supervisor/Manager.
Shift is 8:00am- 8:00pm, Friday - Sunday
Special Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
This position may have the following special vision requirements.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
Preferred:
EQUAL OPPORTUNITY EMPLOYER/DISABLED/VET
Join us and be part of building the bridge between life changing therapies and patients.
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.