What are the responsibilities and job description for the Quality Assurance Specialist position at EPM Scientific?
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.
Salary : $65,000 - $70,000
