Planet Pharma
This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $32.00/hr - $37.00/hr
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 in accordance with Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of the Quality Management System (QMS) and to support the upcoming ERP system deployment. The QA Coordinator will be responsible for processing document control requests, assisting with the ongoing ERP project as needed, and supporting document control duties and training processes within the current eQMS system (Smartsolve). Responsibilities include working with document control and training; interacting with change management, nonconformance, complaint management, CAPA, supplier quality management, internal audits, post‑market surveillance, vigilance management, risk management, product release and design control. The role requires knowledge of MDSAP, ISO 13485 and region‑specific regulations (e.g., FDA 21 CFR 820, EU IVDD).
Qualifications include proficiency in Word, Excel, PowerPoint and data analysis and presentation tools, strong organizational skills, attention to detail, self‑motivation, multitasking ability, and effective communication. The candidate must be a fast learner capable of quickly analyzing and solving problems.
Skills:
Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat (PDF)
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.
Assists with generating, reviewing and maintaining QMS documents.
Assists with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and KPI’s.
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.
Interacts with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
Assists with monthly and management review data and metrics for areas of responsibility.
Other projects or responsibilities as may be required.
Education/Experience:
BA in a scientific discipline or equivalent work experience.
1‑year work experience in quality assurance. Experience with GMP or similar regulated products. GMP/GLP proficiency.
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
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Base pay range $32.00/hr - $37.00/hr
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 in accordance with Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of the Quality Management System (QMS) and to support the upcoming ERP system deployment. The QA Coordinator will be responsible for processing document control requests, assisting with the ongoing ERP project as needed, and supporting document control duties and training processes within the current eQMS system (Smartsolve). Responsibilities include working with document control and training; interacting with change management, nonconformance, complaint management, CAPA, supplier quality management, internal audits, post‑market surveillance, vigilance management, risk management, product release and design control. The role requires knowledge of MDSAP, ISO 13485 and region‑specific regulations (e.g., FDA 21 CFR 820, EU IVDD).
Qualifications include proficiency in Word, Excel, PowerPoint and data analysis and presentation tools, strong organizational skills, attention to detail, self‑motivation, multitasking ability, and effective communication. The candidate must be a fast learner capable of quickly analyzing and solving problems.
Skills:
Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat (PDF)
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.
Assists with generating, reviewing and maintaining QMS documents.
Assists with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and KPI’s.
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.
Interacts with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
Assists with monthly and management review data and metrics for areas of responsibility.
Other projects or responsibilities as may be required.
Education/Experience:
BA in a scientific discipline or equivalent work experience.
1‑year work experience in quality assurance. Experience with GMP or similar regulated products. GMP/GLP proficiency.
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
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