Job Summary:
We are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team.

The Quality Assurance (QA) Specialist is responsible for the review of various documents, protocols, qualifications and/or reports related to Quality Management Systems. This role interacts with clients for quality related issues, as required. The QA Specialist may be asked to participate in regulatory inspections, client audits and internal audits.

Duties/Responsibilities:

· Comply with all company policies, procedures, work instructions and training requirements.

· Assists in the development of quality assurance policies and procedures, quality standards, processes and new models.

· Supports the Production department with process validation and equipment/facility qualifications.

· Assist in the complaint management processes; review, investigate, and prepare responses to complaints made by customers or third parties.

· Assist QA/R Manager with root cause analysis and corrective actions as they relate to complaint investigations.

· Assist with new supplier approvals as part of the supplier approval program.

· Review nonconforming product and recommend disposition.

· Maintain, control, and distribute controlled documents and records related to the Quality Management System.

· Write procedures/work instructions/specifications related to the quality management system.

· Perform and document monthly and quarterly monitoring of cleanroom and warehouse.

· Perform and document qualification, calibration and re-certification of cleanroom and equipment.

· Prepare reports, analyze data and assist Quality Management in development of action plans to achieve departmental benchmarks.

· Provide ongoing support of 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 support function to Quality Assurance Associate as needed.

· Perform other related duties as assigned.

Required Skills/Abilities:

· Good written and verbal communication skills

· Excellent root-cause analysis, problem-solving and analytical skills

· Keen organizational skills and attention to detail

· Teamwork and collaboration

· Ability to use measuring devices like gauges, meters, calipers and computers

· Ability to understand product drawings, specifications and visual work instructions.

· Documentation and reporting skills

· Communicate effectively with technical staff, production teams, and leaders

· Basic computer skills (MS Word, MS Excel, MS Outlook)

Education and Experience:

· High school diploma or equivalent

· 1-2 years of current experience in medical device and/or pharmaceutical industry

· Prior experience working in an FDA regulated environment preferred

Physical Requirements:

· Ability to stand, sit, stoop, kneel, crouch, stretch, and reach with hands

We offer competitive compensation packages and opportunities for career growth. Join our team of dedicated professionals who are committed to delivering high-quality products.

Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of responsibilities or requirements.

Job Type: Full-time

Pay: $24.00 - $28.00 per hour

Work setting:

• In-person

Ability to Commute:

• Alpharetta, GA 30005 (Required)

Work Location: In person