Scientific Associate - Biology B7 II - USA

Job Title: Associate Expert Microbiology
Location: East Hanover, NJ (Onsite)
Pay Rate: $26 - $35
Shift: Work in shifts covering daytime hours from 12 PM to 8 PM and work one or both weekend days at least once per month. Shifts will be fixed based on business needs.

Job Role:
Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department.

Main Activities:
• Perform micro/EM testing in support of clinical release strategies.
• Perform all testing and activities compliantly following appropriate SOPs and procedures.
• Maintain controls and reference standards to support testing.
• Executes and follows SOPs, WPs, and quality policies.
• Peer review and archive analytical data in lab documentation systems.
• Support monthly/quarterly laboratory cleaning.
• Appropriate use of laboratory logbooks and monthly laboratory cleaning.
• Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities.
• Ensures cleanliness of laboratory working areas.
• Support and author OOS/OOE/OOT and deviation investigations.
• Participate in CAPA implementation in a timely manner.
• Follows GxP quality policies and procedures.
• Ensures all assigned training is completed within required time frame.
• Support 5S and Lean projects.
• Identify process improvements.
• Knowledge of LabWare, LIMS and/or other QC data systems.
• Knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.).
• Support execution method qualification/optimization of methods.
• Interface with regulatory agencies during audits as required.
• In addition to these primary duties, provide coverage for all appropriate areas.
• Contributes to assigned projects by following predefined tasks and executing as instructed.
• Perform other job duties as assigned.

Additional specific roles/tasks:
• Collects and generates data for trend reporting.
• Verify the accuracy of data generated.
• Contributes to the gowning qualification program by taking samples and analyzes and generates data.

Ideal Background:
• BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science or equivalent work experience.
• Fluent in English.

Experience/Professional requirement:
• 1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
• Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).
• 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 in various aspects of Client operations.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Strong interpersonal skills which include a professional demeanor when interacting with Client personnel.
• Strong written and verbal communication skills are essential.