Quality Assurance Specialist (5557)

NICE-PAK PRODUCTS LLC•Grand Rapids, MI

12d•Onsite

About The Position

Prioritize daily sample testing and perform a variety of microbiological tests on raw materials and finished batches. Identifies, isolates and studies micro-organisms, bacteria, and their byproducts. Investigate OOS/OOT results and implement any corrective action as determined by QC Management. Aid in training new Associates.

Requirements

Bachelor of Science degree in biology with emphasis in microbiology.
Thorough knowledge of bacterial colony morphology, diagnostic media and rapid methods of organism identification, pathogenic effects of microorganisms, potential environmental contamination factors.
Has a thorough knowledge of laboratory operations and is highly capable of utilizing scientific judgment to assess problems.
Has an extensive knowledge of GMPs and USP regulations in reference to microbial testing?
1-2 years in a microbiology lab.
Aseptic techniques, gram staining, membrane filtration, operation of the autoclave, preferred knowledge of Biology, ADI or other rapid method ID systems, serial dilutions, standard plate counts and work safely with potentially pathogenic microorganisms.
Demonstrated interpersonal skills are vital.
Must be able to work well independently and make quick decisions under pressure.
Computer & related programs, laboratory glassware, sampling equipment, chemical reagents, Federal Register, and standard office equipment.

Nice To Haves

preferred knowledge of Biology, ADI or other rapid method ID systems

Responsibilities

Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts.
Attendance/Punctuality: Presence at work on time when scheduled is a mandatory function
Safety: Compliance with all company safety rules, procedures, and guidelines is mandatory.
Perform and document testing in accordance with cGMP. Testing includes, but is not limited to, finished product analysis and preparatory testing of newly developed products, raw material analysis, and organism identification.
Maintains inventory levels of reagents, media, and stock cultures.
Troubleshooting, maintenance, and calibration of laboratory equipment are expected.
Organize workload of laboratory and provide management with feedback of overall laboratory performance.
Work on special projects as assigned or requested.
Modify SOPs as necessary and ensure that procedures are in place for all tasks within the laboratory.
Perform general housekeeping duties.
Coordinate information flow within the laboratory and to internal customers.
Access, input, and retrieve information from the QC computer systems.
Disposition of raw materials, process samples and finished products for use or sale.
Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy.
Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous and/or flammable products and raw materials in accordance with local, state, and federal guidelines.
Document deviations in performance not anticipated or indicated in test procedures.
Be or become thoroughly familiar with QC and manufacturing process and workflow, QC retain program and documentation procedures.
Work with minimal supervision, re-prioritizing work schedules quickly.
Be proficient in performing traditional plating techniques and routine Celsius analysis.
Become familiar and assist with OOS/OOT and Customer complaint investigations.
Become familiar and assist with Method Development Protocols and conduct requisite testing.
Become familiar and assist with SOP creation, review, and revision activities.
Become familiar and assist with supplies/services ordering process.
Become familiar and assist with instrument maintenance and troubleshooting.
Must be able to perform any routine task in the laboratory in an efficient manner.
Participate in meetings as required.
Complete training assignments as required.
All other duties as assigned.