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Job Description:

Microbiologist - ( 190001D3 )

Description

POSITION SUMMARY

The Microbiologist II is responsible for performing raw material and finished product release at Piramal Pharma Solutions Lexington (PPS) The position performs the related functions such as method development and validation, report generation, test method generation, operation of test equipment, data analysis, organism identification and generation of Certificates of Analysis

PRIMARY RESPONSIBILITIES

Develop microbiological test methods and method validations

Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release

Train new employees in the microbiology laboratory

Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned

Maintain laboratory instrumentation required for testing

Assist in the review of test data and report any deviations to supervisor

Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives

Assist management in writing/updating Standard Operating Procedures (SOPs)

Participate in projects involving the Quality Control and/or Microbiology departments

Train team members in microbiology and chemistry laboratories as required

Ensure proper handling and disposal of biohazard material in compliance with OSHA and Standard Operating Procedures

Perform other related duties as required

WORK ENVIRONMENT

50 PERCENT Computer/office work

50 PERCENT in a clean room or laboratory environment

Ability to work in an office, laboratory and manufacturing setting

Position may require extended hours including evenings and weekends, travel between multiple work sites

Must be able to work independently with minimal supervision

Position may require flexibility in working schedule

Qualifications

QUALIFICATIONS

BS in Microbiology or related Science

Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details

Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves; isolators used for sterility testing, manifold and pump operation, light microscope, biohazard cabinets and water purification system

Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods

Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods

Proficiency in MS Office (ie MS Word, MS Excel, Access, Outlook)

Must understand basic lab safety, bio-hazard and chemical waste disposal practices

Must have a minimum 1-2 years of practical laboratory experience in a manufacturing environment

Strong knowledge of cGMPs and understands the pharmaceutical industry expectations

Familiarity with quality systems such as failure investigations, CAPA, calibration, changes control, etc

Primary Location United States-Kentucky-Lexington

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 25th Feb 2020

Key Skills:

Company Profile:

Company
Piramal Enterprises Ltdarfix

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