Supervisor, Microbiology

SUMMARY:
Under the general supervision of the Director of Microbiology, the Microbiology Supervisor 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 SOP’s and Methods meet Company and FDA standards.
ESSENTIAL FUNCTIONS:
Includes the following. Other duties may be assigned.?
Schedules and supervises microbiological activities to ensure testing is performed and reported in a timely manner.?
Coordinates review and submission of Microbiology batch records to Quality Assurance following completion of testing.?
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, Quality Assurance, Research and Development, and Third Party Business.?
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 employees’ timecards and PTO requests.?
Performs employees’ 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.
ADDITIONAL RESPONSIBILITIES:
Directly supervises exempt and non-exempt staff. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing and training of employees; planning, assigning, and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.

Qualifications

MINUMUM QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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.?
Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.?
This individual must have an understanding of the regulatory guidelines and/or compliance documents.

EDUCATION AND EXPERIENCE:
Requires a Bachelor’s degree in Microbiology and five (5) years of experience in an industrial Microbiology Laboratory. 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.
PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Must be able to meet sterile area gowning requirements and pass routine glove re-qualification. Individual must be able to lift 50 pounds.
Mental Requirements include:?
Ability to hear accurately the spoken word with moderate office noise or plant noise?
Ability to apply deductive reasoning and 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 office stress?
Ability to accurately communicate ideas, facts and technical information?
Maintain confidentiality of certain information

Company Overview

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.

EEO Statement

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.

Auto req ID

2024BR