QA Inspector

Quality Assurance Specialist

Performs sampling of intermediates and finished goods. Inspects, defects and dispositions, according to specific product quality specifications, intermediates and finished goods and documents results in manufacturing batch records. Oversees manufacturing personnel in assigned processing areas and procedures adherence to departmental and company standard operating procedures and GMP guidelines. Performs routine facility environmental testing as well as basic laboratory and manufacturing equipment calibration and assorted physical and chemical testing relating to the manufacture and quality of dietary supplements.

Essential Functions

• Performs sampling of intermediates and finished goods for testing. Enters all required documentation in the sampling specification report, manufacturing batch record and inventory card before and after testing and approval.
• Inspects, defects and dispositions resulting in intermediates and finished goods according to specific product quality specifications. Documents any quality related process and product findings in the manufacturing batch record and, if required, prepares ancillary reports.
• Provides area clearances to manufacturing areas as assigned, prior to dispensing, blending/compounding, encapsulation, sizing and/or inspection, bulk and FG packaging operations.
• Oversees adherence or procedures and personnel to established standard operating procedures and GMP guidelines.
• Responsible for warehouse and production areas environmental and process water monitoring including temperature and humidity control, water sampling and in-process swab sampling for microbiological testing.
• Performs basic laboratory instrumentation and production equipment calibrations. Performs daily checks to ensure that all manufacturing equipment is used within preventive maintenance and calibration periods.
• Reports any safety hazards to Supervisor or Maintenance.
• Performs other duties as assigned by management.

Position Qualifications

Competency Statement(s)

• Positive – Ability to view all situations with a positive attitude.
• Innovative – Ability to look beyond the standard solutions and "think outside the box".
• Detail Oriented – Ability to pay attention to the minute details of a project or task.
• Enthusiastic – Ability to bring energy to the performance of a task.
• Friendly – Ability to exhibit a cheerful demeanor toward others.
• Initiative – Ability to make decisions or take actions to solve a problem or reach a goal.
• Organized – Possessing the trait of being organized or following a systematic method of performing a task.
• Reliability – The trait of being dependable and trustworthy.

Skills & Abilities

Education:

• At least high school diploma

Experience:

• 2+ years of experience in the pharmaceutical industry is preferable.
• Forklift certified (standing and sitting)
• Able to lift, bend, climb and reach. (Forklift training, preferred)
• Good communication skills, including ability to read and write in English. (Bi-lingual language skills in Spanish, helpful but not required).
• Previous QA experience preferred
• Flexibility in work hours preferred.
• Team player, excellent work ethics and able to multitask, attention to details as well as flexibility to changing priorities and due dates.

Computer Skills:

• Analytical, computer and mathematical skills.

Physical Demands

Physical Demands - Lift/Carry

StandF (Frequently)WalkO (Occasionally)SitO (Occasionally)Handling / FingeringF (Frequently)Reach OutwardO (Occasionally)Reach Above ShoulderO (Occasionally)ClimbO (Occasionally)CrawlO (Occasionally)Squat or KneelO (Occasionally)BendN (Not Applicable) - Stand - F (Frequently) - Walk - O (Occasionally) - Sit - O (Occasionally) - Handling / Fingering - F (Frequently) - Reach Outward - O (Occasionally) - Reach Above Shoulder - O (Occasionally) - Climb - O (Occasionally) - Crawl - O (Occasionally) - Squat or Kneel - O (Occasionally) - Bend - N (Not Applicable) - 10 lbs or lessO (Occasionally)11-20 lbsN (Not Applicable)21-50 lbsN (Not Applicable)51-100 lbsN (Not Applicable)Over 100 lbsN (Not Applicable) - 10 lbs or less - O (Occasionally) - 11-20 lbs - N (Not Applicable) - 21-50 lbs - N (Not Applicable) - 51-100 lbs - N (Not Applicable) - Over 100 lbs - N (Not Applicable)

Push/Pull

12 lbs or lessO (Occasionally)13-25 lbsN (Not Applicable)26-40 lbsN (Not Applicable)41-100 lbsN (Not Applicable) - 12 lbs or less - O (Occasionally) - 13-25 lbs - N (Not Applicable) - 26-40 lbs - N (Not Applicable) - 41-100 lbs - N (Not Applicable)