The Quality Control Technician II is an entry level position in Quality Control Microbiology responsible for environmental monitoring and product testing.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Ability to articulate work related issues clearly and effectively to management and peers.
- Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods.
- Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies. Ensure DEA policies related to controlled drugs are adhered to.
- Handling of laboratory instruments such as sterilizers, isolators, total organic carbon analyzer, bacterial endotoxin analyzer.
- Performs other duties as assigned.
- Performs routine and non-routine environmental monitoring according to established procedures.
- Assesses environmental conditions using various methods to sample environment, water systems, compressed gas, and personnel in production areas and microbiology laboratory. Recognizes out of limit results and initiates OOL investigations.
- Must successfully execute requirements to achieve classified areas gowning certification.
- Processes paperwork, LIMS input and approvals for release by QA Critical Systems.
Finished Products Testing
- Performs routine testing of in-process, finished product, raw material.
- Conduct environmental monitoring during bioburden testing and sterility testing.
- Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.
- Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed.
- BS/BA degree in science or related field.
- AS/AA degree with 1-2 years of relevant laboratory experience.
- Working knowledge of cGMPs and GLPs.
- Excellent verbal and written communication skills are essential. Strong attention to details, people skills and ability to multi-task are essential for success.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.