Environmental Sampling Tech

SUMMARY:

The Environmental Technician/Microbiologist will drive quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but not limited to, providing general laboratory support for environmental samples (surface swabs, water and air), raw material, in-process, stability, and finished product testing.

MINIMUM KNOWLEDGE, EDUCATION, SKILLS, & ABILITY REQUIREMENTS:

Associate/Bachelor's degree in biology, microbiology, chemistry, nutrition or related field.
A minimum of three to five (3-5) years of experience in field, laboratory, or production facility quality control strongly (Preferred).
Working knowledge of aseptic technique and serial dilutions.
Must have good understanding of cGMPs and GLPs.
Working knowledge of Microsoft Office products required.
Excellent organizational, written and oral communication skills.
Detail-oriented, ability to multi-task and prioritize tasks with strict deadlines.
Able to use logic and reasoning to identify solutions to problems.
Takes initiative and seeks additional training or direction as needed.
Must be willing to abide by company policies and procedures, including those that are safety-related.
Self-motivated individual willing to work hard, able to work in a group and alone, and be quality conscious.
Demonstrates a professional, team first attitude toward work and co-workers.
Manual dexterity sufficient to operate a wide variety of tools and equipment.
Must be proficient in reading, writing and speaking of English.

WORK ENVIRONMENT:

Manufacturing and laboratory work environment. Constant physical activities are required for this position. Able to tolerate working environment with inside hot and cold temperatures.

PHYSICAL DEMANDS:

Activities include: ability to reach overhead, squat, and bend at the waist; the ability to lift up to 50 pounds or more; ability to climb up and down stairs throughout a shift; tolerance of standing posture continuously during shift; intense walking is involved. Dexterity for manipulating work materials; repetitive motion; proficiency in reading, writing and speaking English. Ability to respond to safety signals, such as those generated by forklifts.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Collection of swabs, water and air samples from different site of production and analytical laboratory area.
Prepare and analyze environmental, raw materials and finished goods according to USP, AOAC, or in-house methodologies and BIOLUMIX.
Prepare and report results and lab notes for environmental and microbiological testing.
Prepare media, reagents, and chemicals for testing purposes and maintain consumables in appropriate storage area.
Test environmental, raw materials, in process, and finished products according to most current and up-to-date specifications.
May assist in conducting stability testing on finished products, R&D samples, manually document and create lab notes.
Assist lab supervisor with calibrations and verifications.
Monitor and maintain microbiology lab inventory.
Organize and maintain environmental testing reports from both internal and external laboratory.
Entering test data in internal system after completion of testing and review. Creating data trends and baselines when applicable.
Sterilize microbial and environmental waste using autoclave and assist in waste pick up.