Quality Assurance Advisor

Job Title: Quality Assurance Advisor

Department: Production

Reports to: Quality Assurance Manager

FLSA Status: Regular- Exempt

Salary: Negotiable

Location: Rochester, New York

ROLE SUMMARY:

The Quality Assurance Advisor works closely with production personnel and quality personnel on the production floor providing guidance on quality decisions and assisting with investigating discrepancies. The Quality Assurance Advisor will also be engaged in the development of quality processes and procedures and develop/ monitor quality metrics.

KEY DUTIES AND RESPONSIBILITIES:

• Designing and implementing tests, debugging and defining corrective actions.
• Review system requirements and track quality assurance metrics (e.g. defect densities and open defect counts.)
• Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
• Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
• Establishes statistical reliability by using mean time before failure, reliability modeling, and reliability demonstration tests.
• Develops experiments to determine best methods.
• Create detailed, comprehensive, and well-structured test plans and test cases.
• Develop and implement procedures.
• Estimate, prioritize, plan and coordinate testing activities.
• Develops sampling plans by applying attribute, variable, and sequential sampling methods.
• Strong statistical process control experience.
• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
• Prepares reports by collecting, analyzing, and summarizing data; making recommendations.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
• Contributes to team effort by accomplishing related results as needed.
• Participates in MRB.
• Analyzes customer complaints.
• Provides support during cGMP and ISO audits.
• Other duties as deemed necessary by management.

SKILLS AND QUALIFICATIONS:

• Strong knowledge of QA methodologies, tools and processes.
• Experience in writing clear, concise and comprehensive control and quality plans.
• Ability to analyze data and create and review processes.
• Highly motivated and self-directed capable of multi-tasking, and able to work with minimal supervision.
• Very strong technical proficiency - must be able to use computers and generate reports.
• Must possess strong communication skills both oral and written.
• Ability to solve complex problems.
• ISO and/ or cGMP experience a plus.
• ASQ certification(s) a plus.
• SAP experience a plus.

ADDITIONAL MINIMUM QUALIFICATIONS:

• Must be able to pass a Level 2 background screening
• Bachelor's degree in engineering, statistics or related field.
• Minimum 3 years of experience as a Quality Engineer in a manufacturing environment.

PHYSICAL REQUIREMENTS:

• Must be able to push, pull, move, and/or lift a minimum of 25lbs to a minimum height of 5 feet and able to push, pull, move, and/or carry such weight a minimum distance of 50 feet, with or without mechanical assistance
• Must be able to work seated/standing as appropriate at workstations for extended periods of time, maintain body equilibrium while climbing ladders, stairways, stopping, kneeling, crouching, and reaching, and use hands/fingers to hold, grasp, turn, pick, pinch frequently/constantly to complete tasks
• Must be able to handle organic matter daily, able to wear PPE as appropriate (eye, face, hand, arm, head, foot, body, fall protection), and able to be exposed to hot, cold, wet, humid, or windy conditions while wearing PPE (95 degrees or greater)
• Must have visual acuity with/without job aids to perform activities such as; reading, viewing a computer terminal, visual inspection involving small parts/details. Clarity of vision at 20 ft or more in day and night/dark conditions
• Must be able to speak and communicate verbally at conversation levels with co-workers, vendors, etc. (Moderate noise)

WORK SCHEDULE:

40 hours weekly with flexible hours depending on department needs. Must be available to work occasional evenings, weekends, and holidays.

Equal Opportunity Employer Golden Bloom Pharms Supports a Drug Free Workplace