Quality Analyst

Position Summary:

We are seeking a Quality Analyst to support our customer’s manufacturing of medical diagnostic products. This is a full time position with Trison, with full benefits package.

The Quality Analyst/Microbiologist in the Fluids Release Laboratory assures the outgoing quality of the Calibrators, Controls, and reagents by executing analytical testing, executing microbiological test procedures, and providing accurate release data to confirm product performance meets specifications and claims.

Responsibilities:

• Works independently to complete microbiological product release tests by performing testing on the traditional media.
• Assures compliance to inspection readiness programs within the organization.
• Performs water and particle testing to assure proper environment is maintained.
• Prepares product samples for multiple groups testing needs asceptically.
• Adhere to quality, GLP, GMP and regulatory compliance policies.
• Maintain equipment, reagents, and supplies. Will require limited work in a freezer.
• Completes analysis of data using spreadsheets or LIMS to report testing results. Reviews data for accuracy and completeness.
• Completes Laboratory Investigations, Non Conformance Records, or Quality Investigations in response to observed trends in a timely manner.
• Careful attention to detail and accuracy of work is essential.
• An understanding of cGMPs and documentation in a regulated industry and experience in documentation protocols and procedures is a plus.
• Planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions
• Perform raw material, intermediates and final product microbiology testing
• Calibrate, troubleshoot and maintain laboratory instrumentation and equipment
• Good written and verbal skills are required to draft and review standard operating procedures
• Participate in laboratory investigations, validations and verifications
• Mathematically inclined to work up chemical calculations for reagent preparation.
• May require over-time and occasional C or B shifts based on production needs and schedule.

Qualifications:

• An Associates or Bachelor’s degree in Medical Technology, Chemistry, Biochemistry, and/or related discipline is required.
• Prefer a minimum 2 years of laboratory experience.
• Must be familiar with aseptic technique for microbiological work.
• Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is preferred.
• Knowledge of QA and QC principles and tools required.
• Ability to multi-task, adapt to changes in daily workload, and contribute in a cross-functional team setting is desired.
• Knowledge of current good lab practices, applicable GMP is required and familiarity with quality audits is recommended.
• Some lifting is required, not to exceed 50 pounds. This position requires working in a lab setting which includes wearing personal protective equipment (PPE) and handling human samples.
• Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.

Potential Safety Hazards:

Chemical and biological handling are required.

Other Information:

This position will be based in Rochester, NY.

Trison Business Solutions, Inc. supports and complies with Equal Employment Opportunity and Affirmative Action act in all employment practices. Accordingly, all applicants and employees will be treated fairly and equally without regards to color, religious creed, national origin, or sex.

Job Types: Full-time, Contract

Pay: From $24.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Weekend availability

Ability to commute/relocate:

• Rochester, NY 14626: Reliably commute or planning to relocate before starting work (Required)

Education:

• Associate (Required)

Experience:

• Microbiology: 1 year (Required)

Work Location: One location