Job Description
Job DescriptionTitle: MicroLab Analyst
Reports to: Supervisory Microbiologist
Department: Quality Control
Responsibilities:
- Perform Micro laboratory testing on raw materials, stability samples, bulk and finished products in compliance with all regulatory standards for Cosmetic (creams, lotions, etc.), Skincare and OTC products (e.g. anti-acne, Sunscreens, etc.).
- Conduct Micro investigation into the growth, structure development, and other characteristics of microscopic organisms such as bacteria, algae, and fungi.
- Perform other micro testing & analysis including monitoring of microbial cultures, samples and such identification. Also maintain supporting procedures and standards as required.
- Support process validation/qualification, equipment/instrument calibration and verifications, including the review of logbooks, instruments, media, etc.
- Review testing with R&D, schedule workload for samples from mfg and pdn.
- Problem solving with colleagues regarding OOS results, discuss additional testing, operation of equipment, meeting to share ideas. CAPA responsibility.
- Assist in drafting NCRs prior to submission to Lab Manager, check calculations, possible cause with review of batch records.
- Assist the Microbiologist/Supervisor in the review of workload priority and staffing requirements with Manager to assure organization priorities are met and communicate priority releases.
- Assist with quality and environmental health and safety audits.
- Maintain experience with Incubators, Laminar Hoods, Bio Safety Cabinets, Autoclaves, Simple and Compound Microscopes, Colony Counter, DI Water Units, Media, Cultures, Standards, Sterilizers, etc.
- Assist in scheduling maintenance services for many different types of Lab equipment.
- Interact with customers, other employees and external contractors.
- Compliance to Data Integrity requirements.
- Assist with investigation of quality issues such Out of Specification, Out of Trends, etc.
- Familiarity in Aseptic techniques and Sterility.
- Familiar with Gram staining, endospore staining techniques, catalase testing, oxidase testing, etc.
- Micro identification techniques is a plus (e.g. Vitek, DNA sequencing [PCR], etc.).
- Familiar with Blood-borne pathogens.
- Familiar with the principles of immunology, virology and microbiology.
- Assist in the training of new micro lab personnel.
- Assist in the management of chemical hygiene program for the laboratory.
- Assist in the management of media, glassware, chemical and consumable stocks.
- Maintain USP/NF Compendia, FDA BAM, AOAC, PCPC Methods, ISO Standards.
- Familiarity with US FDA 21CFR Part 210 & 211 (Drug Product) and Cosmetic GMPs is required.
Qualifications:
- Associate Degree or Bachelor’s degree in Biological Sciences or related life science field, or Engineering or Chemistry.
- Knowledge of GMP, GLP, Root Cause Analysis & Corrective Action Planning Tools.
- Micro Lab experience with Incubators, Laminar Hoods, Bio Safety Cabinets, Autoclaves, Compound Microscopes, Colony Counter, DI Water Units, Media, Cultures, Standards, Sterilizers, micro identification techniques, flaming technique, etc.
- Knowledge of micro challenge testing is a plus.
- Knowledge of Environmental Monitoring is a plus. d. Familiarity with Clean room environment (e.g. Class 7, 8, etc.) is a plus.
- Good interpersonal and written communication.
- Flexible, ability to multitask and designate.
- Good organizational skills.
- Ability to Teach/ Train employees.
- Good Math skills required.
- Ability to lift and carry up to 10 - 15 pounds.
Compensation & Benefits:
-
The approximate pay range for this position is $52,000 - $55,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities.
The benefit package includes:- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
- PTO
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