Manufacturing Quality Assurance Operator- Pharmaceuticals- Ferndale, MI

Manufacturing Quality Assurance (MQA) Operator Job Summary:MQA operator is required to follow written procedures, company guidelines, policies and procedures, and cGMPs.  The jobholder is required to utilize these policies, procedures, and cGMPs to resolve problems.  The jobholder is expected to immediately notify Quality Assurance management of any deviations the jobholder becomes aware of.  Further, the Operator must be able to quickly and concisely relate difficult or complicated information.  The decision made by the jobholder impacts other departments.  Infrequently, the jobholder may be required to train other MQA Operators, assist other QA departments, or assist in conducting standard operating procedure training. Essential Functions: Accurately carry out sampling and visual inspection activities to affect the disposition of finished product. Perform Quality checks, variances and calculation testing. Use handheld measuring devices such as rulers, calibers and be proficient in basic mathematical techniques. Perform line checks and releases. Equipment and Room Testing. Component inspection, material handling, by following GMP guidelines. Perform incoming Label/insert inspections. Update finished product I.D. slips. Recheck of line releases. Must be able to handle inspection activities with the highest degree of accuracy.Additional Responsibilities: This position is required to quickly and accurately carry out sampling and inspection activities to affect the disposition of finished and in-process products.Knowledge, Skills & Abilities:Working knowledge of FDA, cGMP, DEA and ISO regulations.  Must be familiar with American National Standard Z1.4 or equivalent sampling plans.  Basic computer skills, including knowledge of word processing, spreadsheet and database management.  Must be self-motivated; detail oriented; have excellent written and verbal communication skills; and a valid drivers license.  Ability to lift up to 25lbs. Education & Experience:High School diploma or equivalent.  Experience in Pharmaceutical or related industry experience helpful.  Demonstrated strong mathematical skills. Equal Opportunity Employer M/F/V Ferndale Laboratories, Inc. (FLI) specializes in creating and satisfying the demand of premium-quality specialty pharmaceutical products.  Our capable, responsive organization guarantees fast and efficient product development and effective, focused promotional strategies. FLI is headquartered in Ferndale, Michigan.  Please visit our web-site at www.ferndalelabs.com to find out more.