Microbiologist III

Do you want to be part of a winning team?

At VistaPharm, you don't just have a job, you have a CAREER! We hire best in class talent with a wide range of technical skills and diverse backgrounds. Our company believes in promoting internally to help our employees grow with the needs of the business! We offer a competitive compensation package that includes medical plans with 90% of the premium paid for you, a minimum of 26 paid days off annually, 401k matching, free basic life insurance policy, Extraordinary Employee Awards, Service Awards, Employee Referral Program, discounts for Verizon, hotels, rental cars, dell, plus much more!

Your next opportunity awaits you at VistaPharm in Largo Florida!

Job Summary:

In this position the employee will be responsible for supporting the company's Quality Control efforts. This includes the performance of area responsibilities necessary to ensure that Laboratory activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with laboratory objectives.

Job Responsibilities:

1. Participate in project meetings, manage timelines, and review new materials and components for microbiology testing requirements.

2. Participate in project meetings, manage timelines, and review all new products for microbiology testing requirements.

3. Conduct advanced, compendial-based method suitability testing consistent with established methods/specifications as well as USP/NF.

4. Perform microbiology risk assessments on materials and products based on regulatory requirements and VistaPharm quality requirements.

5. Execute method verification protocols and report results to the QC Analytical Support Group.

6. Lead and/or represent QC microbiology in investigations related to microbiology testing or facility issues.

7. Train QC staff, where qualified to serve as a trainer.

8. Execute analytical method transfers and/or participate in co-validation efforts with Analytical Research and Development (AR&D) or Quality Control Analytical Services (QCAS).

9. Participate in departmental projects as assigned by laboratory management.

10. Assist with the implementation of new technology

11. Initiate change controls and document change requests as directed by laboratory management and ensure their timely approval/closure

12. Documents the procedures and results obtained in laboratory notebooks/logbooks according to established procedures consistent guidelines.

13. Assists in installation of new laboratory equipment/ instruments, qualification, calibration and maintenance activities of instruments as directed by lab management.

14. Demonstrate proficiency in QC Microbiologist I and QC Microbiologist II job requirements.

15. This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained in these subjects as per applicable local, state and/or federal regulations.

16. Adhere to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Safety goals.

17. Quality Management, as required, may assign and require other duties and responsibilities not previously mentioned above.

18. Ensure Compliance with cGMPs and current QC Laboratory Standards.

19. Ensure Compliance with Applicable Internal Safety/Security Policies as well as External Safety/Security Regulations.

Qualification and Requirements:

An equivalent combination of education, training, and experience may substitute.

• A four year degree in Microbiology or related natural science with experience in a QC microbiology laboratory environment (5-10 years).
• Prior experience in non-sterile pharmaceutical manufacturing processes is required (5-10 years).
• Knowledge of pharmaceutical quality control, regulatory interactions and cGMP is required (5-10 years).
• Demonstrated written and verbal communication skills.
• Excellent organizational skills.
• Excellent analytical skills.
• Excellent mathematical skills.
• Excellent computer skills.

Equal Opportunities:

As an equal opportunity employer, VistaPharm, Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. It is also VistaPharm’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions

Job Type: Full-time

Pay: $60,000.00 - $62,500.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

COVID-19 considerations:
Employee Safety is a priority at VistaPharm. We have adopted all CDC recommendations to include increased cleaning and sanitizing, temperature taking of all persons and requiring masks while indoors.

Ability to commute/relocate:

• Largo, FL 33771: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• QC microbiology lab environment: 5 years (Preferred)
• non-sterile pharma manufacturing process: 5 years (Preferred)
• pharma qc, ra and cGMP knowledge: 5 years (Preferred)

Work Location: One location