Quality Assurance Coordinator assists local Quality AssuranceOfficer in data quality and integrity oversight and corrective actionsimplementation. Individual will ensure quality systems are functioning withinQSM requirements set forth by the laboratory’s policies and procedures inaccordance to accrediting body and regulatory compliance procedures.
Essential Duties & Responsibilities
- • Performsregular reviews of the quality system and operational activities.
- • Assistsin staff training, including data integrity, quality systems, manualintegration, QC training, and other training as required.
- • Performlaboratory and quality systems internal audits per assigned schedule.
- • Participatein external audits from clients and regulatory agencies.
- • Assistsin reviews and updates of standard operating procedures as needed.
- • Performsweekly trending analysis.
- • Assistsin KPI collection activities
- • Helpsto compile monthly KPI data and oversee corrective actions from KPIs
- • Helpmonitor to ensure the lab is up-to-date with DOC, DOU and annual SOP reviews
- • Assignsand archives logbooks for the laboratory and maintains inventory of controlleddocuments as required.
- • Oversees,processes, and tracks annual MDL Studies.
- • Oversees,processes, and tracks quarterly DOD LOD/LOQ verifications.
- • Reviewssubcontractor reports.
- • Maintainsand updates QAPP worksheets.
- • Receive regular guidance from local QA Officer with respectto overall objectives; work is usually quite independent of others; operatewithin division or department policy guidelines using independent judgment inachieving assigned objectives.
Qualifications EDUCATION & EXPERIENCE
- • Bachelor'sdegree (B. A.) from four-year college or university in LifeScience or related field.
- • One to four year’s related experience and/or training.
- • Ability to read, analyze, and interpret general businessperiodicals, professional journals, technical procedures, or governmentalregulations. Ability to write reports, business correspondence, and proceduremanuals. Ability to effectively present information and respond to questionsfrom groups of managers, clients, customers, and the general public is a plus
- • Ability to work with mathematical concepts such asprobability and statistical inference, and fundamentals of plane and solidgeometry and trigonometry. Ability to apply concepts such as fractions,percentages, ratios, and proportions to practical situations.
- • Ability to define problems, collect data, establish facts,and draw valid conclusions. Ability to interpret an extensive variety oftechnical instructions in mathematical or diagram form and deal with severalabstract and concrete variables.
• Proficient personal computer skillsincluding electronic mail, record keeping, routine database activity, wordprocessing, spreadsheet, graphics, etc. Competencies
- The ability to separate emotional feelings from the real issues at hand. The ability to legitimately and objectively challenge the substance of our beliefs and biases of our observations.
- The ability to meet commitments made to yourself and others, keeping the promises you make, and acknowledging and accepting the choices you have made, the actions you have taken, and the results they have led to.
- Takes personal responsibility and ownership for adhering to all company policies and procedures. Sets high standards and measures of excellence to ensure quality assurance in every aspect of work performed.
- The ability to write and speak effectively using appropriate convention based on the situation; actively listens to others, asks questions to verify understanding, and uses tact and consideration when delivering feedback to others.
- Encourages and embraces dialogue from team members, while anticipating and resolving conflicting differences by exploring mutually agreeable solutions.
- Demonstrate responsiveness and adaptability following change initiatives and demonstrates ongoing support for change efforts.
- Understand and comprehend information, as well as find application and value from new knowledge.
- Methodical and efficient in structuring tasks to be accomplished. Uses time efficiently by prioritizing and planning work activities. Completes work timely and in accordance with performance expectations
- Demonstrates a sound working knowledge of current role and the technical systems, applications and equipment used in performing this role, and understands the impact this role has on other business functions within the organization.
- Demonstrates effectiveness and flexibility with changing environments, responsibilities, tasks, and people.
- Identifies issues timely by gathering and analyzing information skillfully.
- Follows detailed procedures to ensure accuracy in the entry and reporting of data.
- Demonstrates utmost level of integrity in all instances and shows respect towards others and towards company principles.
- Demonstrates ability to make sound decisions in all situations.
- Shares key information with others involved in a project or effort, works in harmony to accomplish objectives, responds with enthusiasm to directives, and shows support for departmental and organizational decisions.
• Raising objects from a lower to ahigher position or moving object horizontally from position to position.
• Light physical activity performingnon-strenuous daily activities of an administrative nature.
• No special vision requirements.
• Exerting up to 25 pounds of forceoccasionally to lift, carry, pull, or otherwise move objects.
• Manual dexterity sufficient to workwith the fingers. Work Environment
• Well-lighted, heated and/orair-conditioned indoor office/production setting with adequate ventilation.
- • Moderate noise (examples: business office with computers andprinters, light traffic).
On site, 9 am to 5 pmwork schedule Monday thru Friday