Job Information
Insight Global Quality Assurance Specialist in Alpharetta, Georgia
Job Description
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.
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.
Annual Compensation:
$70,000 - $80,000
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .
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Skills and Requirements
* 3+ years of experience in a related position within medical device and/or pharmaceutical industry
* Experienced with change control, design control and quality inspection
* Ability to follow SOPs and document control procedures
* Ability to use measuring devices like gauges, meters, calipers, and computers
* Ability to understand product drawings, specifications, and visual work instructions.
* Basic computer skills (MS Word, MS Excel, MS Outlook) null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.