Under limited supervision of the Microbiology Manager and Microbiology Supervisor, the Microbiologist II is responsible for performing microbiological testing of products and raw materials, reading environmental monitoring plates from controlled areas, microbial identification work and other applicable duties.
Include the following. Other duties may be assigned.
- Perform routine microbiological testing of products according to SOPs and Methods.
- Documents routine test data following laboratory and company guidelines and report OOS results
- Reviews and approves the data generated by other Microbiologists.
- Performs microbiological identifications.
- Prepare media and perform growth promotion testing and ensure that media used is correct and within expiration.
- Coordinates and tracks data report as required by other departments.
- Assist generating investigation and/or summary reports under the supervision of Microbiology Supervisor.
- Perform the microbiological support for media fill inspection as per SOPs.
- Assist on the generation of outside source information retrieval and evaluation in support of special project work.
- Perform bioassay testing.
- Inspect instruments and ensure that the instrument used is calibrated and within the calibration date.
- Perform some validation testing of products according to SOPs and Methods
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The individual must be able to work independently with limited supervision as well as work within a team to achieve company goals. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Safety glasses, lab coats and close toed shoes are required in all laboratory areas. Additional safety equipment such as respirators, face shields, or safety shoes etc. may be required for specific tasks.
EDUCATION AND EXPERIENCE:
- Bachelor's degree (B.S.) from four-year college or university with Major in Biology or equivalent and a minimum of two years related experience and/or training in the pharmaceutical industry or life sciences field; or MS degree and no previous experience. Experience with Bioassay testing preferred. Must be computer literate, with experience in Word processing, database, and spreadsheet applications.
- All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
PHYSICAL DEMANDS/ MENTAL DEMANDS AND WORK ENVIRONMENT
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise).
Mental requirements include:
- Ability to write, read and apply technical scientific writing, procedures and quality policies
- Ability to work independently in an efficient and detail-oriented manner.
- Ability to work on multiple projects and priorities in a concurrent manner
- Ability to work in an independent manner, as well as a group environment
- Ability to apply deductive reasoning and analytical thought to understand complicated issues
- Ability to receive instructions and follow work rules and company policies
- Ability to follow safety and security practices.
- Ability to meet deadlines and effectively deal with a high level of office stress.
- Ability to maintain confidentiality of certain information
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
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.