Levels I - IV available
Summary/Objective:
The Quality Assurance Specialist assists with planning, coordinating, monitoring and performing functions related to the quality assurance while ensuring that the entire organization maintains compliance to all GMP requirements.
Essential Functions:
- Conduct day to day quality documentation processing in support of ongoing operations.
- Approving documents that justify in-process controls and in-process specifications.
- Approving specifications including but not limited to raw materials, components, dietary
- Ingredients, finished product, labels, SOP's, testing procedures and deviations.
- Approving documentation for supplier management process (e.g.; approval to use,
- qualified to accept Certificate of Analysis (CoA), etc.).
- Approving documentation for ensuring dietary supplements meet identity, strength, purity
- and composition specification.
- Determining if specifications are met.
- Reviewing and approving documentation, documentation practices and revisions.
- Managing and reviewing change to documents, equipment, and facilities.
- Work closely with internal 2nd and 3rd party audits and preparation.
- Acting as the defined Preventive Controls Qualified Investigator (PCQI).
- Managing the CAPA system.
- Ensuring procedures are followed and the most current revisions of processes and governing documents are in place.
- Conduct training on Quality topics.
- Design, implement and administer quality documentation software such as Master Control, Intelex etc. and also Quality metrics.
- Evaluate quality issues and make decision on appropriate follow-up steps based on established processes and escalation to managers as appropriate.
- Identify opportunities for process and system improvement and enhancement and participate in process/system improvement projects from a Quality Assurance perspective.
- > 40% of plant interactions are required to complete the functions.
- Performing all other Quality Assurance duties that have been assigned by management.
Required Education and Experience:
- Bachelor's degree in a related field or equivalent.
- Experience in manual and electronic document management system in a GMP regulated environment.
- Fluency in the English language.
- Proficiency using standard business software.
Supervisory Responsibility:
None
Work Environment:
Choose an item. Works in a clean, air-conditioned office space, free of noise, dust, and humidity. >40% need to be in the plant environment: exposure to fumes or airborne particles, moving mechanical parts and vibration. Occasionally exposed to a variety of extreme conditions in the plant. The noise level in the plant environment can be loud.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear. Occasional lifting of light items required. No specific vision requirements.
Objects weighing 70 pounds or more must be accompanied by a second individual to avoid injury.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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