Under the general supervision of the Associate Director of Microbiology, the Microbiology Manager ensures staff is trained, troubleshoots microbiological test excursions, develops and implements new microbiological procedures and equipment This individual also ensures testing is conducted in accordance with SOPs and Methods, and ensures department SOPâ€™s and Methods meet Company and FDA standards.
- Schedules and supervises microbiological activities to ensure testing is performed and reported in a timely manner.
- Coordinates EM monitoring activities and ensures the trend reports are completed as per the schedules.
- Conducts or delegates the Purchase Order program for the department while ensuring that the departmental budget is met.
- Supervising training adequacy, adherence to SOPs and methods based on company and regulation standards.
- Coordinates the development and qualification of non-routine microbiological test methods.
- Assists in the coordination of microbiological testing support for Validation, Regulatory Affairs, Quality Control, and Quality Assurance.
- Initiates and assists in performing investigations following deviations and non-conformances in Trackwise software.
- Initiates Change Controls as required by Akorn procedures.
- Ensure lab equipment is adequately maintained and calibrated.
- Coordinates work with Engineering, Metrology, Validation, and other departments as necessary to qualify new equipment.
- Continuously improves SOPs and processes.
- Provide support during internal and external audits.
- Evaluates and approves employeesâ€™ timecards and PTO requests.
- Performs employeesâ€™ performance appraisal in a timely manner.
- Assists in the interview process of new personnel (Microbiologists and Technicians).
- Conduct regular lab meetings and ensure proper communication of business activity to the team.
- Maintain a safe and professional environment in the Microbiology Lab.
Company Overview Who we are?
- Bachelorâ€™s degree (B. S.) in Microbiology or Biological Sciences require
- Minimum five (5) years of experience in an Microbiology Laboratory of pharmaceutical manufacturing of sterile dosages.
- Minimum five (5) years of prior supervisory/managerial experience preferred.
- Experience should include the following: Microbiological isolation, identification, aseptic technique, microbiological test methods for Plate Count Method, Membrane Filtration Method, and Most Provable Number Method, culture maintenance, sterility testing, bacterial endotoxin testing, Bacteriostasis-Fungistasis Test, Anitimicrobial Effectiveness Test, and Bacterial Retention Test.
- An equivalent combination of education and experience may substitute.
- Have knowledge of GMP specializing in sterile dosage forms, USP testing requirements for sterile products and Microbiological procedures, 21 CFR parts 210/211, and other FDA regulations /guidelines
- Must be able to meet sterile area gowning requirements and pass routine glove re-qualification. Individual must be able to lift 50 pounds.
- Ability to follow safety and security practices
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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