Job Description

Description

SUMMARY

Works under the direction of the Quality Assurance Manager to assist and resolve quality problems and is involved in quality improvement projects. The primary focus is the Operations groups defined as manufacturing (reagents & instruments), production (filling & packaging) and, shipping/receiving.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Member of the internal audit team.
• Monitors and reviews the manufacturing, production, and shipping/receiving processes through direct observation or through hands-on involvement.
• Participate in the development and revision of written procedures and work instructions.
• Works with various teams to plan, design and execute projects.
• Lead Test Method Validation (TMV) and Inspection method Validation (IMV) activities; including writing validation protocols (process and IQ/OQ/PQ) so others may follow and execute. Will write the protocol report and present the conclusions.
• Possess a sound understanding of the corrective action process. Will monitor and drive the CAPA program.
• Oversee the resolution of non-conformances. Ensure thorough investigations are conducted.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Requires an above average understanding of the 5-Why root cause and fishbone methods of root cause determination.
• Lead all activities for Non-Conformance Materials Reports (NCMRs). Including, the investigation and root cause analysis.
• Review and approve Process Failure Mode and Effects Analysis (pFMEA), Installation Quantification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).
• Participate in or lead cross-functional teams in supporting quality disciplines, decisions, and practices.
• Initiate and participate in change control activities.
• Coordinates the environmental monitoring program.
• Responsible for implementing quality assurance principles throughout the operations groups.
• Possess above average oral and written skills.
• Gather and report key performance metrics to senior management.
• Performs duties in a manner to ensure quality and regulatory compliance.

Requirements

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s degree (B.A or B.S.) in a science-related field; or three to five years related experience and/or training or a combination of education and experience and/or training. Knowledge of quality concepts is necessary.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to read and understand reports, business correspondence, and procedure manuals. Ability to effectively write and present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

TRAINING REQUIREMENTS

To be trained according to all job related standard operating procedures, Quality System Regulations (cGMP, ISO) as well as all other regulatory & safety requirements.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is routinely required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and to talk or hear. The employee is occasionally required to sit; climb or balance, and stoop, kneel, crouch, or crawl. The employee may be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and depth perception.

WORK ENVIRONMENT

While working in the laboratory, employees are required to wear latex gloves, lab coats, safety glasses, shoe covers and hair nets. Beard covers are also required if needed.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and fumes or airborne particles. However, by wearing the appropriate safety equipment, the risk of serious health concerns is greatly reduced. The employee is occasionally exposed to extreme cold. The noise level in the work environment is usually moderate.