QC Microbiology Analyst I
The ideal candidate for this position may have experience in the Quality department of a pharmaceutical or medical device company. This position will require that the analyst conducts microbial based assays including antibiotic potency testing, bioburden testing, microbial quantification, and organism identification.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Perform antibiotic potency assays, microbial isolation techniques, gram stains, and support microbial identification process.
- Perform testing to bioburden analysis, biological indicators, growth promotion, and water quality monitoring.
- Perform microbial and particulate monitoring of clean rooms throughout the facility.
- Read microbial plates and interpret test results.
- Perform review of test data with apply Good Documentation Practices (GDP).
- Use LIMS or other computerized systems for entering and approving test results.
- Will be required to perform change requests (e.g. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined.
- May be required to conduct investigations into Alert/OOS excursions.
- Ensure laboratory area is maintained in a cGMP state at all times while following all EHS and 5S guidelines. Will be expected to do laboratory walk throughs to ensure area is suitable for hand off to oncoming shifts.
- Actively contribute to a team setting within the laboratory and other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
- Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
- Support deviation investigations, utilizing problem-solving tools as needed.
- Support execution of validations for lab equipment, lab methods, or facility projects.
- May perform other general laboratory duties as assigned.
Position Type/Expected Hours of Work
This is a full-time on-site position. The candidate must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
The Ideal Candidate
- Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
- Effective organizational skills and ability to plan and suggest resolutions to technical problems.
- Demonstrated working knowledge of assays/equipment in functional area.
- Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).
- Must be detail-oriented, conscientious, and responsible.
- Effective interpersonal communication. Must have effective verbal and written communication skills.
- Can demonstrate the ability to guide people, encourage teamwork, and teach assays.
- Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
- Good project management skills a plus.
- Must be able to learn new computer systems and programs in a timely manner. Education and/or experience
- Bachelor's degree in Microbiology, Virology or another biological science with Laboratory coursework with 0-2 years of relevant experience. Physical Demands
- Must be able to lift, push, pull 25 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. Working Environment
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
About the Company
For over 35 years, we’ve committed to serving the animal health community by providing products to extend the health span of companion animals and ensure a safe and abundant food supply. We believe every animal deserves proper care, that’s why we aim to create accessible and results-driven, quality products.
Dechra Pharmaceuticals PLC