EM Analyst

Primary responsibilities

• Performing tasks associated with critical testing on raw materials, environment, utilities, validation samples, and manufactured materials.
• 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.
• 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.

Minimum Requirements (Must Have)

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

Desired Requirements (Nice To Have)

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