Senior Associate I, QC Microbiology

Job Responsibilities

• Perform Bioburden and endotoxin testing of in-process and products samples.
• Environmental monitoring (EM) of classified cleanrooms and controlled areas.
• Collect and test water samples from purified water and WFI systems.
• Revise SOPs and Test Methods as required.
• Review data generated in the Microbiology lab.
• Execute method suitability testing, performance qualifications and various studies.
• Conduct investigations of microbiological Quality Events and support CAPA implementation.
• Collaborate cross-functionally with Manufacturing, QA, and Validation teams.
• Author quarterly and yearly trend reports.
• Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements.

Requirements

• Education and Experience: BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience. BS with 3 years or MS degree with 0-3 years of progressively responsible experience in pharmaceutical or biologics production environments, or equivalent combination of education and experience.
• Knowledge, Skills And Abilities: Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices. Knowledge of standard laboratory equipment. Basic understanding of microbiological techniques, aseptic practices, and laboratory safety. Good organizational and problem-solving skills. Ability to follow written procedures and work in a regulated environment. Must always adhere to good documentation practices. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Willingness to work in cleanroom settings and handle biohazardous materials under proper PPE and gowning protocols. Experience with Microsoft suite (e.g. PowerPoint, Word, and Excel).

Pay

$66,421 - $74,588