Performs microbiological testing on raw materials, in-process and finished product samples.
This position is responsible for the following:
- Performing microbiological tests and interpreting the results based upon the Standard Operating Procedures.
- Prepare microbiological media.
- Receives and/or prepares supplies and media.
- Environmental and facility sample collection.
- General laboratory cleaning and sanitation.
- Entering data from testing for trend analysis.
- Performing routine cleaning of incubators and refrigerators.
- Maintain all necessary documentation regarding the activities listed above.
- May perform equipment calibrations.
- May assist with microbial investigations.
- May prepare trend analysis and reports.
- Perform any other tasks/duties as assigned by manager.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
Two (2) years of experience in pharmaceutical manufacturing microbiology lab or similar laboratory experience.
Essential Knowledge, Skills & Abilities:
- Strong math skills, including the comprehension of metric weights and measures, performing complex calculations, and spreadsheet management.
- Ability to perform detailed tasks and document activities accurately.
- Able to work in an aseptic controlled environment which includes wearing PPE, aseptic gowning qualifications, and subsequent gowning requalification’s.
- Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts).
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Ability to read, comprehend, write, and communicate effectively in English.
- Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Experience with SAP preferred.
- Strong written and verbal communication skills.
- Ability to work with minimal supervision.
- Physically able to continuously stand and walk.
- Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
- Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
Significant Work Activities: N/A
Job Type: Experienced