What are the responsibilities and job description for the Quality Assurance Coordinator position at Revvity?
Overview:
BioLegend (a division of Revvity, Inc.) is seeking a highly motivated Quality Assurance Coordinator. The Quality Assurance Coordinator will be a multi-faceted and integral part of the Quality Assurance team and will perform and administer Quality Assurance (QA) activities at BioLegend, in accordance with BioLegend Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS) and support the upcoming ERP system deployment. The QA Coordinator will be responsible for processing document control requests as well as assisting with the ongoing ERP project as needed, while supporting document control duties and training processes within current eQMS system (Smartsolve) as needed. Responsible for working with one or more of the following quality system processes: document control and training. Interacting with other QA departments and processes: change management, nonconformance, complaint management, CAPA management, supplier quality management, internal audits, post-market surveillance and vigilance management, risk management, QA product release and QA design control responsibilities. The QA Coordinator is responsible for ensuring quality systems procedures are followed and records are compliant in their applicable areas of responsibility. This role requires some work experience and knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD).
Qualified individuals must also be proficient in computer word processing using Word and in other data analysis and presentations programs such as Excel, and PowerPoint. The QA Coordinator should possess strong organization skills and attention to detail and accuracy and they must be self-motivated, able to multi-task, and work effectively in a fast-paced environment; Good communication and interpersonal skills are essential in interactions with employees and others. The QA Coordinator must be a fast learner with the ability to quickly analyze and solve problems.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.
The base salary range for this full-time position is $56,500.00 - $62,400.00. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
BioLegend (a division of Revvity, Inc.) is seeking a highly motivated Quality Assurance Coordinator. The Quality Assurance Coordinator will be a multi-faceted and integral part of the Quality Assurance team and will perform and administer Quality Assurance (QA) activities at BioLegend, in accordance with BioLegend Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS) and support the upcoming ERP system deployment. The QA Coordinator will be responsible for processing document control requests as well as assisting with the ongoing ERP project as needed, while supporting document control duties and training processes within current eQMS system (Smartsolve) as needed. Responsible for working with one or more of the following quality system processes: document control and training. Interacting with other QA departments and processes: change management, nonconformance, complaint management, CAPA management, supplier quality management, internal audits, post-market surveillance and vigilance management, risk management, QA product release and QA design control responsibilities. The QA Coordinator is responsible for ensuring quality systems procedures are followed and records are compliant in their applicable areas of responsibility. This role requires some work experience and knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD).
Qualified individuals must also be proficient in computer word processing using Word and in other data analysis and presentations programs such as Excel, and PowerPoint. The QA Coordinator should possess strong organization skills and attention to detail and accuracy and they must be self-motivated, able to multi-task, and work effectively in a fast-paced environment; Good communication and interpersonal skills are essential in interactions with employees and others. The QA Coordinator must be a fast learner with the ability to quickly analyze and solve problems.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Acts in a support capacity for critical QMS processes such as, non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing, supplier Management and validation.
- Reviews quality records for all related areas of responsibility.
- Demonstrates the ability to work with limited direction and can prioritize projects independently
- Responsible for personal daily task management, training plans and performance management.
- Assist with generating, reviews and maintains QMS documents.
- Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
- Assists with data preparation for Quality Management Reviews.
- Provides administrative support for external audits (regulatory or customer) and Internal Audits.
- Participates in the use of the eQMS system and expanded applications as appropriate.
- This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
- Assist with monthly and management review data and metrics for areas of responsibility.
- Other projects or responsibilities as may be required.
- Bachelors in a scientific discipline or equivalent work experience.
- A minimum of 0-1 work experience in quality assurance. Experience with GMP/GLP or similar regulated products.
- Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)
- Associates Degree or equivalent work experience.
- A minimum of 2 years' work experience in quality assurance. Experience with GMP/GLP or similar regulated products.
- Experience in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF)
- IVD, MDSAP, ISO 13485 or similar compliance experience
While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.
The base salary range for this full-time position is $56,500.00 - $62,400.00. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.
What do we offer?
We provide competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:
- Medical, Dental, and Vision Insurance Options
- Life and Disability Insurance
- Paid Time-Off
- Parental Benefits
- Compassionate Care Leave
- 401k with Company Match
- Employee Stock Purchase Plan
For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
Salary : $56,500 - $62,400