Microbiologist I, Sterility Assurance

Quality & Compliance Rochester, Michigan


Description

Microbiologist I, Sterility Assurance, Quality / Quality Control Laboratory, Michigan-Rochester

 

About Endo International plc

Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide.  For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89.  Learn more at www.endo.com.

 

POSITION SUMMARY:

Performs Quality Sterility Assurance microbiological analyses of materials including water testing, environmental monitoring, media fill.   Participates in investigations.  Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.

 

ROLE AND RESPONSIBILITIES:

Microbiology Lab-Sterility Assurance

  • Conducts microbiological analyses: water testing, environmental monitoring, media fill program monitoring.
  • Performs day-to-day operations of Sterility Assurance to ensure that cGMPs, GLPs and all other applicable compendia requirements are met.
  • Performs environmental monitoring with high degree of efficiency/reliability/accuracy
  • Performs critical utility monitoring
  • Media Fill Observation
  • Records results from tests, interprets colony morphology, and accurately maintains laboratory data.

Compliance

  • With guidance, detects and participates in OOS/NOEs and other investigations.
  • May assist in performing Sterility Assurance audits of facilities.
  • Follows internal processes related to controlled substances.

SOPs

  • Reviews and updates SOPs and procedures for Quality as needed. 
  • Reviews and comments on the articles affecting Quality in the USP Supplements and Pharmacopeial Forums.
  • Oversees maintenance, logbooks, media, and sterilization documents.

Lab Equipment

  • Maintains laboratory equipment in clean order; reports equipment problems to supervisor.

Safety

  • Follows EH&S procedures to ensure a safe work environment.
  • Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.

 

REQUIRED QUALIFICATIONS:

Education & Experience

  • Bachelor of Science degree in microbiology, biology or related field with microbiology

Knowledge

  • Proficient with Sterility Assurance techniques and instruments.
  • Learns regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.
  • Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.
  • Competency in Microsoft Office Suite.
  • Knowledgeable in aseptic techniques.

Skills & Abilities

  • Ability to display and analyze data in a logical manner.
  • Good verbal and written communication skills as well as good computer skills.
  • Attention to details and accurate record keeping.
  • Ability to establish and maintain cooperative working relationships with others.
  • Solid organizational skills.
  • Ability to take initiative, set priorities and follow through on assignments.

 

PHYSICAL REQUIREMENTS:

  • Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.  Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.
  • Must occasionally lift and/or move up to 15-25 lbs.
  • Ability to wear personal protective equipment, including respirators, gloves, etc
  • Specific visions abilities are required by this job include close vision and color vision.
  • Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.
  • The work environment is representative of a group laboratory and manufacturing area activities including the following:
    • Wet or Humid
    • Work near moving mechanical parts
    • Work in high, precarious places
    • Fumes or airborne particles

 

ADDITIONAL INFORMATION:

  • Afternoon shift premium is 10% (non-union positions only)
  • Midnight shift premium is 15% (non-union positions only)

 

 

Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.

 

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

 

*LI-ENDP