Summary of Functions:
Ensure quality of operations and data being produced in the laboratories by performing data review, auditing laboratories, investigation/corrective action follow-up, and reviewing written procedures.
Associate responsibilities include, but not limited to, the following:
- Independently perform duties, both routine and non routine, completed in a reliable and accurate manner.
- Understand basics of technical procedures.
- Endure the integrity of the final report of analysis being in compliance with all regulatory and company standards
- Primary QA reviewer of all analytical data generated in the laboratory and performs weekly review of all logbooks, temperature tracking documents and any other related logs maintained in the laboratory.
- Ensures that Standard Operating Procedures are being followed. Assist with issuance, review, revisions, and archiving of all quality documents.
- Assist in maintaining the company’s training program assuring that all personnel receive adequate training to perform their job functions in accordance to the cGMP’s.
The ideal candidate would possess:
- A Bachelor’s degree, with a major in science
- Previous related laboratory and QA experience
- Experience with industrial microbiology, specifically Microbial Limits Testing USP<61><62>, Antimicrobial Effectiveness Testing USP<51>, And Microbial Water analysis per USP<1223> and Standard Methods for the Examination of Water.
- Experience with industrial biology, specifically Biological Reactivity Tests In-Vitro and In-Vivo (USP<87><88>), and Endotoxin testing (USP<85>).
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part as a team, self-motivated, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Basic Minimum Qualifications:
- Bachelor’s degree biology, microbiology or other related degree concentration, or equivalent directly-related experience (two years of direct related industry experience is equivalent to one fill-time year of college in related major)
- Computer skills including word processing, spreadsheets, and database
- Authorization to work in the United States indefinitely without restrictions or sponsorship
Position is a full-time, Monday-Friday, 8 a.m.-5p,m.
Reports to the Quality Assurance Manager
EDUCATIONAL OR SKILL REQUIREMENTS:
A college degree is required with a major in science preferred or relevant work experience preferably in a contract testing laboratory subject to cGMP’s. Good grammar and written/oral communication skills are required. Must be detailed oriented and prior Quality Assurance experience is essential.