Job Number: 21-11905
Job Number: 21-11905
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Training Specialist for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- This position will work both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
- The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities
- assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by the management
- Additional Job Requirements: Position Handles Hazardous Materials
- Good knowledge of Microsoft Word and Excel.
- Responds to challenges and additional projects in an understanding, positive, and objective manner.
- Adaptable to dynamic conditions, work practices, and project timelines.
- Ability to multitask, prioritize workload and interpret data accurately.
- Able to communicate effectively with GDPO functional areas and external agencies.
- Fosters teamwork and promotes an environment that motivates others to achieve our goals.
- Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab experience & Master's Degree strongly preferred. An equivalent combination of experience/education is acceptable.
- Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
- Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
- Follow directions properly, work cooperatively as an individual contributor and as a team member.
- Communicate effectively with QC peers, cross-functional peers and management.
- Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
- Train Bacterial Endotoxin and Sterility Testing.
- Train growth promotion testing of microbiological media.
- Train mycoplasma testing and PCR.
- Train Environmental Monitoring on routine basis.
- Train microbial isolation techniques and perform Gram stain identifications.
- Train "Send out samples” to contract labs and track results/reports.
- Experiences on HPLC, UPLC, or GC is plus.
- Performs general laboratory cleaning/wipe-down.
- Perform routine maintenance of lab equipment's.
- Under the guidance of management, support special project work.
- Maintain lab inventory and order lab supplies and materials.
- Support continuous improvement projects related to QC
- Assist with investigations &CAPAs associated with Microbiological testing.
- Support data trending and tracking of results.
- Perform all other duties as assigned.
- Using MET ONE and MAS 100/ SAS instruments
- Perform surface viable sampling
- Use of Pipettes
- Gram Staining
- Endotoxin testing
- Experience with Client T or Observa preferred
- Working Conditions (US Only):
- The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment.
- The incumbent may be required to stand and walk for extended amount of time.
- The incumbent may be required to work hazardous materials.
- Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
- Flexible to work shift structures.
- Change to work timings and assigned tasks may occur at a very short notice to support business needs.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.