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Senior Microbiologist

CoreRx
Full-time
On-site
Clearwater, Florida, United States

WHY CORERX?



CoreRx is a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx, our biggest asset is our people, and the service and solutions they provide to our partners; you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.



Our employees enjoy a competitive benefits package, including:

  • Competitive compensation with an annual discretionary incentive bonus!

  • Affordable healthcare insurance (Medical, Dental, Vision)

  • Health Care Flexible Spending Account

  • Employer paid LTD, STD, and Life Insurance coverage

  • Paid Time Off (PTO), 15 days pro-rated your first year + 10 Paid Holidays

  • 401k with 100% employer match up to 3%

  • Tuition Reimbursement, Perks at Work Employee Discounts, Employee Assistance Program, and Adoption Assistance Program


The Senior Microbiologist is an integral part of the team, contributing to our success by leading all activities related to the microbiology laboratory.



E
SSENTIAL JOB DUTIES



Primary Responsibilities/functions:

  • Oversee microbiology laboratory compliance to ensure all microbiological testing procedures/methods are properly performed and manage efficiency of operations and continuous improvement activities

  • Provide training, mentoring, and career development to team members

  • Prepare SOP’s, work instructions, reports and all other documents related to microbiological testing

  • Ensure testing is properly conducted and documented for all performed activities with emphasis on data integrity

  • Ensure all materials (media, reagents, standard organisms, etc.) and equipment used for testing are valid, qualified or calibrated as required

  • Oversee and perform as necessary microbiological testing of raw materials, finished and stability pharmaceutical drug products, environments monitoring samples from utilities and facilities, and equipment cleaning validation samples

  • Responsible for media, reagents, standards, tools, and instrument/equipment procurement

  • Notify management immediately of nonconforming data or unexpected occurrences and conducts deviation and laboratory investigations as required

  • Complies with all regulatory/in-house requirements may include but not be limited to safety, housekeeping, laboratory waste, cGMP, documentation

  • Performs other related duties as assigned by management


REQUIRED SKILLS/ABILITIES

  • Experience in environmental monitoring and microbial testing of pharmaceutical products

  • Knowledge with microbiological equipment

  • Working knowledge of Health Authority expectations for microbiology laborator facilities and procedures

  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result -driven and highly flexible team-player in a fast-paced working environment

  • Proficient in Microsoft Office Suite or similar software


WORK EXPERIENCE AND REQUIREMENTS

  • Minimum of 2 year’s experience preferred in an FDA-regulated pharmaceutical environment

  • Experience in other highly regulated laboratory settings will be considered


EDUCATION REQUIREMENTS

  • MS in Microbiology preferred

  • BS/BA in microbiology or life sciences required

  • Equivalent experience may substitute for stated requirement


PHYSICAL DEMANDS

  • Regularly required to stand for long periods. Frequently required to sit, walk, talk, hear, handle or feel tools or controls

  • Occasionally required to reach with hands arms, stoop, crouch climb or balance, kneel

  • Vision suitable for performing detailed inspections

  • May be required to move items weighing up to 25lb

  • Ability to community clearly in both written and verbal form


WORK ENVIRONMENT

  • Pharmaceutical microbiology laboratory environment

  • General office setting



Notification to Agencies:


Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensation.


Job Type: Full-time