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Aerotek QA Auditor in Montague, Michigan

Description:

2 Second Shift QA Auditors (Train on 1st shift for at least six months)

The break down of the Quality Auditors role will look like this:

They will start their day by reading emails and reviewing any outstanding responsibilities. They then will have a meeting with production to discuss goals for the day. Their essential duties will be drafting/editing batch records (a batch record is a "recipe" that's to be followed during the production process), SOPs, auditing production and ensuring procedures are being followed.

Additional responsibilities include:

  1. Perform product manufacturing audits throughout process through observation and by conducting in-process testing to ensure product meets specifications.

  2. Conduct packaging audit ensuring final product meets packaging specifications and is within the allowed accepted quality limits (AQL); inspect all incoming packaging components, ensuring specifications are met by performing appropriate tests following determined component specifications.

  3. Conduct investigations as directed and collect information to assess root causes when product or processes are not meeting specifications.

  4. Assist in the conduct of internal audits of cGMP to ensure compliance to cGMP and internal procedures and policies.

  5. Audit finished/completed batch production documents for procedural or mathematical errors prior to final review and release of product by the QA Manager.

  6. Communicate identified manufacturing deficiencies to key personnel (Machine Operator, QA Manager, Technical Director, Production Manager, & VP of Operations).

  7. Perform daily humidity reading in designated manufacturing areas and determine grains of moisture using appropriate equipment and computer software.

  8. Verify that all instrumentation used are calibrated and perform equipment calibrations as identified.

  9. Perform all work in accordance with established Safety, cGMP and company procedures.

Additional Skills & Qualifications:

1-2 years of FDA or experience following and understanding Pharmaceutical guidelines

Experience following cGMP guidelines

Experience using MS Word and MS Excel

Strong writing skills

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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