Quality Assurance Specialist - Alpharetta, United States - TRC Talent Solutions

Description

Job Description

Job Description
Quality Assurance Specialist

Job Summary:
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 Senior 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)
• Must be able to read, speak and write effectively in English

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
• Must be able to lift and move up to 50 lbs.

TRC Talent Solutions is proud to be an Equal Opportunity Employer (EOE).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.