Quality Operations Specialist
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
This position will be responsible for activities related to finished goods testing and on-going monitoring of product to support continued released of finished product. Additionally, the role may be trained for monitoring the performance of the Controlled Environment(s) and utilities such as the DI Water System(s), Compressed Air System(s) and other functionalities to support the Environmental Monitoring Program.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Assist in the collection of finished products for submission of products for Bacterial Endotoxin Testing to support product release.
- Manage the collection of finished products for execution of routine product bioburden testing and quarterly dose audits.
- Compile test results that support sterilization of finished product to facilitate release of product for saleable inventory.
- Monitor results and manage facilitation of questions, issues and variances that occur related to sterilization and finished product testing.
- Generate non-conformance reports as necessary and support investigations related to sterilization, product release or environmental monitoring.
- Collect, compile, and report results through monthly metrics, trend reports, and dashboards
- Document and generate reports for routine bioburden and dose audit studies.
- Assist in the compilation of devices and/or data related to sterilization validation work as guided by Product Sterilization Specialist or management.
- Execution of sampling for controlled manufacturing areas via contact plates, impact plates, and a particle counter.
- Collection of water samples and monitoring of water systems for compliance to specifications
- Submission of environmental monitoring samples to 3rd party test lab(s)
- Coordination of 3rd party suppliers to execute HEPA filter pressure certification for controlled manufacturing areas and sampling of compressed air systems
- Document and generate reports for routine Environmental Monitoring and Product Testing.
- Support team with remediation, and quality system tasks including investigations, CAPAs, etc.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Flexible schedule – some weekend work as needed
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
- High school diploma required or demonstrated equivalent combination of education, training and experience
- Working experience in regulated environment, with familiarity to cGMPs, 1 year minimum
- Computer/data entry skills
- Written/report writing skills
- Good interpersonal skills
- Verbal communication skills
- Intermediate Microsoft Office skills (Excel, Word, PowerPoint)
- Problem solving skills
- Ability to prioritize multiple projects
- Travel up to 10%
- Associates Degree
- Strong understanding of cGMPs
- Knowledge of aseptic technique
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to regularly lift up to 25 pounds, occasionally lift up to 50 pounds
- Ability to pass pre-employment drug screen and background check
- Job Family Quality Technician
- Job Function Quality
- Pay Type Hourly
- Employment Indicator Non Manager