Quality Assurance Associate

This position is responsible for quality management system (QMS) programs at the Springfield, MO facility. This can include, but is not limited to data reporting and trending, program support, investigations, applicable training of employees, auditing, and document control.

Essential Functions and Responsibilities (not restrictive)

• Periodic (daily, weekly, monthly, ad hoc) data trend reporting
• Key user of CAPA (Intelex) system
• SQF Practitioner
• Manage and trend key QMS programs (EMP, CAPA, Sanitation, Pest Control, auditing, etc.)
• Facilitate material disposal requests (MDRs)
• Generate various QMS related reports as required
• Ensure clean equipment swab program is implemented and monitored.
• Provide applicable quality system training
• Conduct root cause analysis and corrective/preventive action.
• Serve as back up to Documentation Specialists, QA Technicians and PRP Technicians for basic functions of their jobs.
• Provides input into quality management system programs for review and revision.
• Perform other duties as assigned.

When the employee(s) filling this position is absent from their job, their immediate supervisor/manager (as identified in the “Reports To” section of this job description) is responsible for assigning the qualified employee(s) to perform the essential functions and responsibilities listed in this job description. The qualified employee(s) must have been successfully trained on the assigned temporary duties. 

Supervisory Responsibilities (if applicable)

• Not Applicable

Performance indicators (related to above Task & Responsibilities, respectively)

• Ensure no MDR materials exceed 30 days in blocked stock.
• Timely completion of MDR documentation.
• Retention sample put away on a regular frequency.
• Timely completion of Quality System issue escalation.
• Timely completion of CRM responses and customer complaints.

Qualification & Experience Requirements

Education, Training:

2-4 year college degree is preferred.

Alternately, High School education with strong, relevant industry experience will be acceptable.

Experience Required:

• Two years in an industrial quality or micro lab application in the food, dietary supplement or pharmaceutical industry is preferred
• Experience with GFSI standards (BRC, SQF, FSSC 22000) preferred

Knowledge, Skills, Abilities:

• Working knowledge of good manufacturing practices and quality assurance fundamentals
• Strong interpersonal and communication skills (written and verbal), to include speaking clearly and persuasively in positive or challenging situations.
• Must be able to lead root cause analysis and corrective action plans

• Effectively handles multiple, rapidly changing and conflicting priorities and works well under pressure.

Language, Computer &   Numeracy:

• Proficiency with Microsoft Office Applications including, but not limited to, Word, Excel and Outlook
• Ability to generate routine reports and correspondence
• Experience in SAP and LIMS a plus
• Fluent in written and spoken English required

Personality, Characteristics:

• Works with minimal supervision and remains productive at all times.
• Must be results-focused and oriented toward accomplishment of team.

• Must be able to work flexible hours to include daily overtime and some weekends when needed.
• Operates well in a team environment and possess team-based problem solving skills.
• Results focused and oriented toward accomplishment of team and organizational skills.
• Stays positive and calm in difficult and/or trying circumstances.
• Able to work flexible hours to include overtime when needed.
• Ability to effectively interact with all levels of personnel with the utmost professionalism.

Travel requirements:

• Minimal domestic travel (<5%)

Typical Physical Activity

Physical Demands:

• Regularly involves talking or listening, sitting, and the use of hands/fingers.
• Regularly involves going up and down stairs.
• Frequently involves reaching with hands and arms, standing and walking.
• Occasionally involves crouching, stooping, kneeling and/or climbing or balancing.

Physical Requirements:

• Must be able to lift and carry items weighing up to 50 pounds.
• Manual dexterity sufficient to reach/handle items, works with fingers, and perceives attributes of objects and materials.
• Involves moderate physical activity performing non-strenuous daily activities of a primarily administrative nature.
• Should be able to identify and distinguish colors, see clearly at 20 inches or closer and while eyes are fixed on a given point, judge distances and spatial relationships, and adjust the eye to bring an object into sharp focus.
• Must be able to pass respiratory exam and fit test.
• Ability to work while wearing Personal Protective Equipment (PPE) including respirator (which requires minimal to no facial hair).

Typical environmental conditions

• May be exposed to moderate noise levels (i.e. office equipment, light traffic).
• May be exposed to moderate to high noise levels (i.e. production equipment, forklifts, heavy traffic).
• May be exposed to dust, humidity, intense heat and cold, outdoor weather conditions, and fumes and toxic chemicals.
• May work in areas with mechanical moving parts, above ground with risk of fall, or areas with risk of electrical shock.

disclaimer

Must perform the essential duties and responsibilities with or without reasonable accommodation efficiently and accurately without causing significant safety threat to self or others.  The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.