Associate Expert Science & Technology

Role Summary

Associate Expert Science & Technology – on-site in East Hanover, NJ. Under general direction, perform microbiology and environmental monitoring (EM) testing and other activities in support of the Quality Control department. Relocation assistance is not offered; local candidates only.

Responsibilities

• Shift position: Work on shifts covering daytime, evening, and one or both weekend days. Shift will be fixed according to business need.
• Perform microbiology/EM testing in support of clinical release strategies.
• Perform all testing and activities compliantly following SOPs and procedures.
• Maintain controls and reference standards to support testing.
• Execute and follow SOPs, work instructions (WPs), and quality policies.
• Peer review and archive analytical data in lab documentation systems.
• Support monthly/quarterly laboratory cleaning.
• Maintain appropriate laboratory logbooks and cleanliness of laboratory areas.
• Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibility.
• Ensure cleanliness of laboratory working areas.
• Support and author OOS/OOE/OOT and deviation investigations.
• Participate in CAPA implementation in a timely manner.
• Follow GxP quality policies and procedures.

Qualifications

• BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science, or equivalent work experience.
• 0–3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
• Knowledge of cGMP and understanding of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (e.g., ANSI, ISO).
• Thorough knowledge of microbiological and environmental monitoring test methods.
• Microbiology/Environmental Monitoring knowledge to facilitate investigations.
• Knowledge of LIMS systems.
• Ability to communicate clearly with a variety of individuals across the organization.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.

Skills

• Knowledge of LIMS systems
• Clear communication across the organization
• Detail-oriented with problem-solving and decision-making abilities