Job description
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.
Excited to grow your career?
We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!
Our people make all the difference in our success.
Summary:
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 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 records and specifications.
NOTE: Employees who have received a counseling report for a violation occurring within the last 3 months are not eligible to apply for open positions.
Qualifications Required:
High School Diploma or GED • 2 years of experience in Operations/Quality and/or providing support in an office or manufacturing environment. .
Skills and knowledge:
- Basic Mathematical Skills
- 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.
Preferred
- Ability to follow instructions and respond to management direction; identify and resolve problems in a timely manner; hold oneself in a professional manner and attention to detail.
EQUAL OPPORTUNITY
EMPLOYER/DISABLED/VETERANS
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.
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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.
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.
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