Job Number: 24378666
Pay ranges between $23 - $26.50 per hour.
- Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment.
- An equivalent combination of experience/education is acceptable.
- Microbiology lab experience strongly preferred.
- Understanding of USP, EP, JP, and FDA microbiology testing requirements.
- 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.
- Working Conditions:
- 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 an 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.
- Changes to work timings and assigned tasks may occur at very short notice to support business needs.
- 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.
- 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.
- Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.
- Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
- Perform Bacterial Endotoxin and Sterility Testing.
- Perform growth promotion testing of microbiological media.
- Perform Environmental Monitoring on a routine basis.
- Perform microbial isolation techniques and perform Gram stain identifications.
- Send out samples to contract labs and track results/reports.
- Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
- Performs general laboratory cleaning/wipe-down.
- Perform routine maintenance of lab equipment.
- Under the guidance of management, support special project work.
- Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.
- Maintain lab inventory and order lab supplies and materials.
- Receives and stocks test reagents, lab supplies and test media.
- Support continuous improvement projects related to QC.
- Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports in support of projects.
- Assist with investigations &CAPAs associated with Microbiological testing.
- Support data trending and tracking of results.
- Perform all other duties as assigned.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: jacqueline@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01195
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE