Now Hiring:

Microbiology Analyst I or II

Department:
Quality Control
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 Med-Pharmex is presently pursuing top talent in the areas of Quality Control to expand our research and development capability. Ideal candidate should have experience in pharmaceutical prescription drug development, either in new or generic drugs, with generic experience being preferred. 

Summary: 

The Quality Control Microbiologist will perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen, etc. Conduct microbial based assays including bioburden testing, microbial quantification, and organism identification. 

Essential Duties and Responsibilities: 

  • Perform microbial and particulate monitoring of clean rooms throughout the facility. Work under some Supervision. May be responsible for overseeing daily workflow of assigned area. 
  • Testing as required supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, and water groups. Will be required to read microbial plates and interpret test results. Some troubleshooting will be required. 
  • Perform review of test data with application of GDP. 
  • Use Global LIMS or other computerized systems for entering and approving test results. 
  • Will be required to perform change requests (e.g. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined. 
  • Identification and issuance of Alert/OOL forms for out of limit results. May be required to conduct investigations into Alert/OOL excursions. 
  • Ensure laboratory area is maintained in a cGMP state at all times while following all EHS and 5S guidelines. Will be expected to do laboratory walk throughs to ensure area is suitable for hand off to oncoming shifts. 
  • Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. 
  • Provide training and some work direction for assigned functional areas as required. 
  • Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner. 
  • Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed. 
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. 
  • Support execution of validations for lab equipment, lab methods, or facility projects. 
  • May be required to generate, execute, and summarize special laboratory studies. 
  • Drive Lean principles such as 5S throughout daily work activities. 
  • Ensure personal training requirements are met and that training records are current. 
  • May perform disposal of hazardous waste. 

Qualifications 

  • Ability to handle multiple tasks concurrently and complete tasks in a timely manner. 
  • Effective organizational skills and ability to plan and suggest resolutions to technical problems. 
  • Demonstrated working knowledge of assays/equipment in functional area. 
  • Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office). 
  • Must be detail-oriented, conscientious, and responsible. 
  • Effective interpersonal communication. Must have effective verbal and written communication skills. 
  • Can demonstrate the ability to guide people, encourage teamwork, and teach assays. 
  • Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs. 
  • Good project management skills a plus. 
  • Must be able to learn new computer systems and programs in a timely manner. Education and/or experience 
  • Bachelor’s degree in Microbiology, Virology or another biological science with Laboratory coursework with 0-2 years of relevant experience. Physical Demands 
  • Must be able to lift, push, pull 25 lbs and carry up to 50 lbs. 
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility. Working Environment 
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. 

Position Type/Expected Hours of Work:

This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time. 

Med-Pharmex is an Equal Opportunity Employer. The policy Med-Pharmex is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, protected veteran status, sexual orientation, genetic information, or any other protected category recognized by state and federal laws. 

Application for
Microbiology Analyst I or II

Upload Resume/CV & Cover Letter. If separate documents, select all at same time. Accepted Files types: .pdf, .doc, .docx, .zip  Max size 6MB

Med-Pharmex, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By submitting this form, you acknowledge that this is only one of several phases in the recruitment process at Med-Pharmex, Inc. Should you be selected for an interview, you will be contacted by a member of our recruiting team to submit a formal employment application.

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