QA Inspector

Miami, FL

Posted: 06/20/2019 Job Number: JN -062019-10894
QA Technician/Inspector-3rd shift

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: QA Technician/Inspector-3rd shift
Location: Miami, FL
Industry: Pharmaceutical
Hours: Tuesday-Saturday, 10pm-6:30am
Salary: $17.00/hr.-$20.00/hr.
Employment Type: Permanent
OVERVIEW:
  • Inspect inbound components for manufacturing / packaging activity.
  • Enforce cGMP compliance of manufacturing and packaging staff.
  • Review and release Labels assuring compliance with quality specifications.
  • Ensure that manufacturing and packaged products meet quality and customer standards and guidelines.
  • Review in process and completed batch records and shipment paperwork for accuracy, completeness and adherence to cGMP.
  • Assist in conducting site cGMP training.
  • Review and update Standard Operating Procedures, track quality investigations, process deviations and follow up to ensure corrective actions are taken.
  • Carry out duties in compliance with all state and federal regulations and guidelines, including FDA, specifically 21 CFR 111, 211 and 117.
  • Ensure compliance of Manufactured/ Packaged product to FDA and regulatory standards.
  • Monitor manufacturing / packaging process throughout its entirety.
  • Review and disposition of nonconformance product.
  • Assist Sanitation Supervisor on the overseeing of allergen program.
  • Perform ATP Swabs on equipment after allergens.
GENERAL DESCRIPTION:
  • Monitors packaging operation for cGMP compliance.
  • Reviews processing information, such as room and equipment logs, product processing sheets, and specification sheets to verify that records adhere to specifications.
  • Performs in-process control tasks as needed.
  • Assists in batch record verification and customer complaints investigation.
  • Assists in staff training.
  • Review and release Labels assuring compliance with quality specifications.
  • Review and release packaging components in compliance with quality specifications.
WORK EXPERIENCE AND SKILLS REQUIREMENTS
  • Minimum 3 years experience within an FDA environment
  • Ability to deal confidently and effectively with all levels of employees to express ideas concisely and in an orderly, disciplined manner both written and orally.
  • Good understanding of cGMP and FDA regulations, specifically 21 CFR 111, 211 and 117.
  • Driven, Organized; detail oriented.
  • Able to effectively communicate in English written and oral.
  • Able to prioritize multiple work assignments.
  • Must be able to stand their ground and act in the interest of quality
  • Able to see colors.
  • Able to follow routine verbal and/or written instructions.
  • Able to work under pressure and meet deadlines.
EDUCATION REQUIREMENTS
  • High School Diploma with previous experience in FDA regulated industry; Associate degree in Sciences or related discipline is a plus.

EOE/ADA
Search words: Inspections, master batch records, labels, auditing, deviations, investigations, raw materials, packaging, QA, compliance, Quality Assurance, Inspector
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