Quality Coordinator
About The Position
The Quality Coordinator assists with coordinating quality activities for a designated Customer Focused Team to help ensure its goals and objectives are completed within prescribed time frames and budget. The role helps drive project success and support long-term quality customer management. The position prepares and distributes production work-order documentation; reviews completed order records for compliance with cGMP requirements and customer requirements; creates and updates batch records, forms, and material specifications; and coordinates internal and customer approvals. It also submits batch records, accountability reports, and other documentation to customers to facilitate product release, helps identify and resolve documentation issues, serves as a customer contact for batch-documentation questions, provides quality-related metrics, and performs finished-product batch release for approved production lots. The role reviews and interprets customer standards, procedures, and specifications for use in batch records, forms, and material specifications, and meets with management regarding batch-documentation issues. Adherence to PCI, cGMP, and GCP policies and procedures is required. Overtime and/or weekend work may be required.
Requirements
- Meet TABE testing requirements at the approved grade level for the position.
- Basic mathematical skills.
- Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
- Full professional proficiency in speaking, reading, and writing fluently and accurately at levels pertinent to professional needs.
- Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions in mathematical or diagram form, and handling abstract and concrete variables.
Nice To Haves
- Ability to follow instructions and respond to management direction.
- Ability to identify and resolve problems in a timely manner.
- Ability to conduct oneself professionally.
- Attention to detail.
- High school diploma or GED.
- Two years of experience in Operations/Quality and/or providing support in an office or manufacturing environment.
Responsibilities
- Prepare and distribute required documentation for requested production work orders.
- Review completed order documentation and records for compliance with cGMP requirements and customer requirements.
- Create and update batch records, forms, and material specifications, and organize internal and customer approval.
- Submit batch records, accountability reports, and required documentation to customers to facilitate product release.
- Help identify, communicate, track, and resolve document-related issues with other departments and customers.
- Serve as a customer point of contact for comments or questions about batch documentation.
- Assist with providing quality-related metrics.
- Perform finished-product batch release of approved production lots.
- Meet with management to address batch-documentation issues or concerns.
- Review and interpret customer standards, procedures, and specifications for dissemination relative to batch records, forms, and material specifications.
- Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
- Perform other duties as assigned by the Manager or Supervisor.
Benefits
- Paid time off.
- Health insurance coverage, including dental and vision.
- Flexible spending account.
- 401(k).
- Eligibility for an annual performance bonus.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
