Quality Support Activities

Actively participates in the maintenance and improvement of the company's Quality/Business System with the "ownership" of job specific processes and participation of related processes and teams.

Purchase Order Review

Provides support to assure compliance of products received to products ordered.

Supplier Qualification

Supports Materials Management in the evaluation, selection, monitoring and measurement of supplier quality.

Technical Operation Activities

• Represents QC team regarding ongoing projects during product launch and / or special projects.
• Analyzes raw, in-process materials and finalized products using IHC, ISH, ELISA and molecular/ biochemical techniques.
• Analyzes, documents, and interprets test results according to established quality control guidelines.
• Manage documentation update project within the QC department.
• Inspects in-process and final products.
• Monitors various quality control equipment parameters to ensure proper calibration and operation.
• Maintains laboratory instruments and facilities in good working condition.
• Executes and completes validation protocols for processes and test equipment.
• Updates management of any and all issues that may affect product quality.
• Cleans lab area and biosafety cabinets.
• Maintain QC retention area and samples.

Technical Operation Activities (continued)

• Communicate with Production Management in order to schedule activities to meet customer orders and maintain proper inventory levels.
• Performs inspection of incoming and in-process inspection of components and finished goods for all company products.
• Perform investigative research with discrepant materials and processes; compile information, analyze issues related to root causes; initiate corrective action for procedural, product or process deficiencies.

Information Management & Reporting Activities

• Performs data analysis.
• Provides feedback by preparing charts, graphs, reports and other methods of communication as to how well the Quality System is working.

Other Activities

• Provides support in review, analysis, and input to Specifications, DCO's, ECO's, Technical Manuals, Bulletins, Advertisements, and etc.
• Draft and assist in establishing Operating Procedures (OP).
• Provides support to propose, evaluate, and validate equipment to be used by QC.
• Process Control. Provides support in initiation, audits and verifications of compliance of processes prior to first product acceptance.
• Assists in field failure analysis, and corrective action. Provides liaison to Product Support, R&D and Technical Service Departments.
• Training. Assists in training programs to ensure that personnel who may impact product quality are qualified to perform their special functions. Assist in training newly hired colleagues in quality area.
• Document and maintain: Document and control nonconforming products via MRB logs. Maintain lab supplies to meet production demands.

Education

• BS or BA degree in Biological Sciences, Biochemistry or equivalent combination of education and experience. Additional course work in quality and quantitative methods a plus. Previous system/process auditing a plus.

Experience & Minimum Qualifications

• Five - six years of related experience or equivalent combination of education and experience.
• Previous GMP/GLP experience.
• Ability to work independently and effectively troubleshoot.
• Ability to independently prioritize work and schedule activities in such a way as to meet established deadlines and accomplish goals and objectives.
• Ability to adapt to constant changes and work effectively under pressure and time constraints.
• Ability to deal with problems involving product failure, analysis and remedial actions with minimum supervision.
• Effective communication skills. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Excellent mathematical skills. Ability to apply advanced mathematical concepts such as exponents, logarithms, and quadratic equations.
• Knowledge of biochemical processes including Spectrophotometry, Bacterial Culture, Chromatography, PCR, Probe and In-situ hybridization, Antibody and Immunohistochemistry (IHC), Mammalian cell culture, DNA and RNA, Cell Blocks.
• Knowledge of Quality Control and Assurance methods, principles and practices; inspection/calibration techniques and systems, interpretation of technical specifications.

Experience & Minimum Qualifications (continued)

• Ability to get along well with diverse personalities. Must be tactful and flexible.
• Possesses excellent communication skills with department personnel, management and suppliers.

Physical Requirements & Working Environment

• Ability to lift 50 lbs with assistance.
• This position frequently works in a laboratory environment.
• Ability to work safely and proficiently in a shop environment with a variety of instruments and tools.
• Ability to travel to other locations both within and outside of the local region.
• Ability to read and analyze hard written copy and information on a computer screen.
• Ability to successfully respond to multiple work pressures.
• Ability to listen, resolve problems, and manage tasks.
• Ability to effectively communicate verbally and in writing to individuals and groups.

• Ability to meet multiple deadlines and work under time constraints.
• Ability to effectively interact with diverse personalities. Must be tactful and flexible.
• Must be able to manage change effectively.
• This position requires the employee to frequently sit. In addition, the employee is occasionally required to stand, walk, use hands and fingers and reach with hands and arms.