EM Analyst

About the role

Primary responsibilities for this position include performing tasks associated with critical testing on raw materials, environment, utilities, validation samples, and manufactured materials. The analyst will be responsible for ensuring that QC Microbiology samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers. Performs testing and associated tasks without errors per applicable SOPs and protocols. Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written. Develops and maintains SOPs. Develops expertise in assigned assays/techniques. Authors lab investigation and invalid assay assessments. May be required to perform shift work as required to support the operations.

Responsibilities

• Perform critical testing on raw materials, environment, utilities, validation samples, and manufactured materials
• Collect, test, and review QC Microbiology samples according to quality requirements
• Ensure results reported are valid, accurate, and documented per applicable regulatory and corporate requirements
• Perform or participate in tasks associated with method validation and transfers
• Perform testing and associated tasks without errors per applicable SOPs and protocols
• Comply with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements
• Develop and maintain SOPs
• Develop expertise in assigned assays/techniques
• Author lab investigations and invalid assay assessments
• Perform shift work as required to support operations

Requirements

• BS/BA in Biology or Microbiology or other related science field
• Experience with environmental monitoring in manufacturing areas
• Some experience with working in an analytical testing lab (academic or industry)

Qualifications

• Bachelor’s degree in Scientific discipline and 3+ years’ experience or associate’s and 5+ years of industry experience or equivalent
• 3+ years of laboratory experience OR equivalent preferred
• Intermediate knowledge of GMPs, safety regulations and data integrity
• Intermediate knowledge of analytical methods and related instrumentation

Skills

• Experience performing Environmental Monitoring within a pharmaceutical environment
• Experience performing Bioburden, Endotoxin, and Sterility

Preferred Skills

• Experience working in a cGMP Pharmaceutical Laboratory
• Experience with Laboratory Information Management Systems (LIMS)
• Experience performing Bioburden, Endotoxin, and Sterility