Location: Buena, NJ
Responsible for performing routine Microbial Limits Testing and/or Method Suitability as well as media receiving and growth promotion, water testing / sampling, environmental monitoring. Also responsible for new SOPs implementation, revisions and training. Perform inventory and ordering of test materials to be used in the Microbiology Lab. Reports to Quality Control Manager and Microbiology Supervisor. This role has potential for advancement for the right individual.
- Microbial Limit Testing for topical products.
- Bacterial Endotoxin Testing
• Bioburden Test
• Media Growth Promotion
• Topical and Injectable Product Microbial Method Validation
• Raw Material Microbial Method Validation
• Environmental Monitoring for non-sterile and sterile manufacturing areas
• Purified Water and Water For Injection Testing
• Antimicrobial Effectiveness Testing
• cGMP Compliance
• Laboratory Investigation Reports
• SOP Revisions/ Creation
- Assumes other activities and responsibilities as needed, including but not limited to Purified Water testing not specific to microbiology, provide support if needed during weekends. Train new personnel as well as re-train employees. Supervisor designee on different meetings when Supervisor is not present.
- Excellent organizational skills.
- Demonstrated ability to work to multitask, work in many different areas of micro simultaneously, and meet timelines.
- Detail oriented and able to work on multiple projects at the same time, achieving deliverables in the allotted time.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Adheres to Teligent’s standards of business conduct and company expectations.
- Good written and oral communications.
- Time flexibility to support manufacturing and laboratory needs.
- Bachelor’s degree in Microbiology or related discipline and a minimum of 3 – 5 years of bench experience in a microbiology or aseptic laboratory.
- Injectables experience preferred.
- Proficient in aseptic technique.
- Write Standard Operating Procedure (SOPs), Job Aids, Investigations
- Have the ability to test a large volume of work both efficiently and accurately.
- Demonstrated ability to work on multiple projects and meet timelines.
- Knowledge of cGMP requirements. Practical experience with document control.
- Strong knowledge of Microsoft Word.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs