Overview
Quality Assurance Specialist Jobs in Atlanta, GA at EPM Scientific
Title: Quality Assurance Specialist
Company: EPM Scientific
Location: Atlanta, GA
Quality Assurance Specialist with Growing Medical Device Company
Metro Atlanta Area
Salary range of $65,000 to $70,000
Local Candidates Only
Job Summary: The Quality Assurance (QA) Specialist is tasked with reviewing various documents, protocols, qualifications, and reports related to Quality Management Systems. This role involves interacting with clients on quality-related issues as needed. The QA Specialist may also participate in regulatory inspections, client audits, and internal audits.
Duties/Responsibilities:
Adhere to all company policies, procedures, work instructions, and training requirements.
Assist in developing quality assurance policies, procedures, standards, processes, and new models.
Support the Production department with process validation and equipment/facility qualifications.
Aid in the complaint management process by reviewing, investigating, and preparing responses to customer or third-party complaints.
Assist the QA/R Manager with root cause analysis and corrective actions related to complaint investigations.
Help with new supplier approvals as part of the supplier approval program.
Review nonconforming products and recommend dispositions.
Maintain, control, and distribute controlled documents and records related to the Quality Management System.
Write procedures, work instructions, and specifications related to the quality management system.
Perform and document monthly and quarterly monitoring of cleanroom and warehouse.
Conduct qualification, calibration, and re-certification of cleanroom and equipment.
Prepare reports, analyze data, and assist Quality Management in developing action plans to achieve departmental benchmarks.
Provide ongoing support for the day-to-day activities of the Quality Assurance team and work with Quality Management to ensure daily goals and metrics are met.
Act as a support function to the Quality Assurance Associate as needed.
Perform other related duties as assigned.
Required Skills/Abilities:
Strong written and verbal communication skills
Excellent root-cause analysis, problem-solving, and analytical skills
Strong organizational skills and attention to detail
Teamwork and collaboration abilities
Proficiency in using measuring devices like gauges, meters, calipers, and computers
Ability to understand product drawings, specifications, and visual work instructions
Strong documentation and reporting skills
Effective communication with technical staff, production teams, and leaders
Basic computer skills (MS Word, MS Excel, MS Outlook)
Proficiency in reading, speaking, and writing in English
Must be a permanent resident of the U.S.
Education and Experience:
4 year Bachleor’s degree strongly preferred but not required
3-5 years of recent experience in the medical device and/or pharmaceutical industry
Prior experience in an FDA-regulated environment preferred
Physical Requirements:
Ability to stand, sit, stoop, kneel, crouch, stretch, and reach with hands
Must be able to lift and move up to 50 lbs.
