Technician II, Manufacturing Quality Assurance 3rd shift

POSITION SUMMARY STATEMENT:

The MQA Technician II is responsible for conducting quality control checks of materials, products and documentation before, during and after batch production activities. They are also responsible for conducting sensory, physical and chemical testing of in-process materials to verify they meet specifications.

DETAILED RESPONSIBILITIES/DUTIES: 

• Perform pre-batch inspection activities (e.g., verify line clearance, review of staged materials, review of batch-related documentation, inspection of initial units, line release, etc.), swabbing of equipment to verify cleanliness before use, and in-process quality control checks for low- and high-speed Powder and Tea packaging lines and Liquid packaging line
• Perform sensory, physical and/or chemical analysis of in-process materials to confirm they meet specifications
• Assist production staff with the correct understanding and implementation of GMP procedures and company policy
• Document and investigate (as appropriate) foreign materials and metal discovered during manufacturing and packaging activities
• Perform swabbing of manufacturing equipment to verify cleanliness
• Perform in-process quality control checks
• Ensure batch-related documentation is completed accurately and completely in real-time
• Change the status of production materials to released, rejected, hold, etc.
• Document quality-related incidents using appropriate GMP documentation (e.g., nonconforming materials report, unplanned deviation report, quality incident report, etc.)
• Review production-related GMP documentation (e.g., production logbooks) to ensure they are being completed accurately and completely.
• Report any violations of GMP procedures or company policy to MQA management
• Performs other related duties as assigned by management.

SUPERVISORY RESPONSIBILITIES:

None

  #LI-SE1!

REQUIRED QUALIFICATIONS:

Skills:

• Attention to detail
• Good interpersonal and communication skills
• Ability to communicate effectively verbally and in written English
• Computer literacy, with solid PC and software experience
• Ability to lift a minimum of 30 lbs
• Strong ability to work independently and as a team member under the pressure of manufacturing
• This position will require the employee to operate a motorized powered lift i.e. Forklift, Scissor lift, one man lift, etc. A MVR (Motor Vehicle Report) will determine an employee’s eligibility to operate these lifts.

Experience:

• A minimum of 2 years of experience in FDA or GMP regulated industry

Education:

• High-school diploma (or equivalent)

PREFERRED QUALIFICATIONS:

• Experience with food, supplement or pharmaceutical manufacturing
• Knowledge and understanding of GMP quality systems