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:
- High School Diploma or GED
- • 1-3 years related experience and/or training.
- • Basic Mathematical Skills • Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
- • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
- High Standard of Report Writing Preferred:
- Ability to follow instructions and respond to management direction
- Ability to work independently and/or part of a team.
- Ability to display excellent time management skills
- Ability to demonstrate attention to detail.
- The candidate must be able to demonstrate basic proficiency with computers, business software (eg MS Office) and technical software (eg Master Control). Ability to create, use and interpret scientific tables, charts, and graphs.
EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED
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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.
Top Skills
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.
