Under limited supervision and guidance of the Microbiology management team, the Microbiologist II is responsible for the following duties:
- Performs routine microbiological testing of products, raw materials, components and controlled environments according to site Standard Operating Procedures and compendial methods.
- Knowledge of or experience in the following:
- Method Suitability and routine:
- Sterility Testing by Membrane Filtration and Direct Inoculation
- Bioburden Testing by Membrane Filtration and Pour Plate Method (formulated product, raw materials and packaging components)
- Antimicrobial Effectiveness Testing
- Antibiotic Microbial Assays for Potency Determination
- Bacterial Endotoxin Testing
- Sampling of Sterile Raw Materials
- Total Heterotrophic Plate Count of potable and Process Water
- Preparation, Sterilization, Incubation, and Growth Promotion of culture media
- Disinfectants and lethality studies
- Population Determination and Testing of Biological Indicators; operation of autoclaves
- Identification of microbial organisms
- Documents routine procedures following laboratory and company guidelines.
- Data entry using Good Documentation Practices
- Assists in non-conformance investigations including deviations, and OOT/OOS related to product results.
- Issues and revises GMP documents such as SOP's, protocols/reports, testing monographs, data sheets, etc.
- Assists in trainings of new employees.
- Identifies and implements improvement opportunities in the Microbiology laboratory, including continuous quality improvement.
- Other duties as assigned.
Company OverviewWho we are?
- Degree, in a Scientific Discipline, preferably Microbiology
- Minimum of four years' experience in the pharmaceutical industry working in a GMP Microbiology or Environmental Laboratory.
- Equivalent combination of education and experience acceptable.
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 patients' 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.