Job description
Overview:
The Manufacturing Quality Coordinator serves as a quality support function within the Manufacturing department. Individuals in this role are self-starters and can operate with minimal supervision. This is an administrative role that will interact routinely with front line personnel, area supervision and managers.
Responsibilities:
- Responsible for in-process review of batch record documentation for manufacturing activities. Data review is not limited to primary documentation and associated forms and equipment-generated reports.
- Responsible for coordinating with Process Supervision and QA to obtain required corrections, and escalation of any atypical findings during review.
- Maintain record tracking database and ensure documents remain in a secure location.
- Represent Manufacturing in meetings related to record review and completion.
- Observe activities on the manufacturing floor and engage with Process Owners to gain the process knowledge needed to effectively review batch record documentation.
- Supports and maintains an environment that fosters communication and teamwork within the Operations Group and other departments.
- Perform ERP transactions as assigned.
- Work in Trackwise to complete corrective action records and effectiveness checks.
- High school degree with a minimum of 5 years of relevant experience.
- Associate’s degree with a minimum of 3 years of relevant experience.
- Bachelor’s degree with no experience.
Relevant experience is defined as prior experience with aseptic processing, pharmaceutical experience, or prior experience in an equivalent role.
- Must have a thorough understanding of cGMP and GDP requirements.
- Must be able to think critically and exercise sound judgment when performing administrative tasks.
- Must be able to navigate company quality and/or enterprise systems as needed to perform assigned tasks.
- Must be able to provide direction to individuals on the front line.
- Must be able to report, read, and interpret metrics.
- Must be able to read and interpret documents in English and be able to write routine reports and correspondence.
- Must be able to speak effectively before groups of customers or employees of the organization.
- Must be able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Must work independently and be flexible to changing priorities. Strong personal computer skills.
- Must have excellent teamwork, communication, and organizational skills. Must be resourceful, self-reliant, self-motivated, and confident.
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