Microbiology Associate Scientist

Microbiology Associate Scientist

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees.

Your role

Reporting to the Microbiology Supervisor ,

JOB SUMMARY:
Perform routine evaluations of raw materials, finished products, components, stability, and special project test samples as directed by supervisor. Perform environmental monitoring to support manufacturing and packaging operations using suitable instrumentation according to cGMPs. Supports laboratory to ensure laboratory procedures, equipment, supplies, and inventory are available for routine testing, monitoring, and for qualification and implementation of newtests and equipment.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Sample Testing and Environmental Monitoring
Perform routine microbiological analyses and reporting of raw materials, components, stability, sample requests and finished products, including but not limited to Microbial Limits.
Perform environmental monitoring of purified water, water for injection, clean steam, compressed air and non-sterile manufacturing operations.
Perform duties that support the laboratory function such as media preparation, housekeeping, use of autoclaves.
Ability to aseptically gown required.
Ability to work aseptically in a lab setting as well as aseptic processing area.
Actively participates in job training.
Handle and reconcile controlled substances.
Participate in investigations.
Perform Visual Inspection.
Perform Particulate Matter Testing.
Handle Biological Indicators.
Maintain Stock Cultures.
Perform Microbial Identifications.

Laboratory Environment Maintained to GMP Standards
Prepares media, reagents, and diluents as needed.
Provides support for start-up functions, including but not limited to, balance checks, temperature checks, calibration checks, and remediation of biological wastes as needed.
Performs laboratory glassware washing as needed.
Autoclaves utensils, reagents, media, diluents and test equipment as needed.
Performs laboratory file maintenance.
Monitors equipment certification/calibration schedules and schedules associated calibration/certifications

Inventory Maintained at Appropriate Levels
Maintains supply inventory through ordering, receipt and rotation of supplies.
Performs inventory.

Safe, Compliant,Efficient Labs
Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, CDC/NIH and OSHA regulations.

Your profile

EDUCATION & EXPERIENCE:
High School Diploma/GED required;
Associates degree in Biology or related field preferred
Minimum 1 year prior cGMP or regulated environment experience (including internships/ co-ops) required.

KNOWLEDGE SKILLS & ABILITIES:
Ability to read, communicate and legibly write in English, analyze and interpret scientific and regulatory documents.
Ability to apply and understand general mathematical concepts such as exponents, averages, and logarithms.
Ability to apply principles of logical and scientific thinking to a wide range of practical and applied problems.
Ability to work independently and in a team environment and take the initiative to learn new techniques.
Effective planning, organization, and prioritization of multiple work assignments and/or projects.
Must have excellent attention to detail and the ability to follow procedures and perform tasks with a high degree of accuracy and quality.
Ability to quickly learn and demonstrate comprehension of cGMPs and SOPs.

COMPUTER SKILLS:
Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
Basic