Quality Assurance and Regulatory Specialist
1 week ago
Key Responsibilities:
As a Quality Assurance and Regulatory Specialist at Applechem, you will be responsible for managing customer inquiries and complaint resolution processes related to product quality. You will also oversee the Corrective and Preventive Action (CAPA) program under the direction of the Quality Assurance Manager.
Key Responsibilities (continued):
You will provide oversight of Non-conformance, Internal Deviations, and equipment calibration and maintenance programs. Additionally, you will review internal production batch records for release and monitor incoming raw materials and finished goods release process with Quality Control.
Key Responsibilities (continued):
You will manage and monitor vendor, supplier, and OEM onboarding assessments to ensure that requisite quality documentation and quality management systems are in compliance with Applechem quality standards. You will also facilitate document control by creating and revising SOP's for quality processes for R&D, Production, Order Fulfillment, and other business units involved in API Manufacturing operations.
Requirements:
- A Bachelor's Degree is required, with a strong preference for candidates holding degrees in scientific fields.
- 3-5 years of experience in Quality Assurance and/or Regulatory roles within regulated industries.
- Knowledge and understanding of ICH Q7 cGMP and ISO 9001:2015 Quality Management Systems Standards.
- Working knowledge of relevant federal and state regulatory statues, including CFR 21 FD&C Act and OSHA Hazardous Communications Standard.
- Basic understanding of EU REACH regulatory framework is preferred.
- Advanced skills in MS Office applications, particularly Word and Excel.
- Excellent attention to detail with strong communication skills.
- Excellent proficiency in English, with proven ability to proofread and edit technical documents.
About the Role:
This role is responsible for ensuring that Applechem's quality management systems are in compliance with regulatory requirements. The successful candidate will have a strong understanding of quality management systems and regulatory requirements, as well as excellent communication and analytical skills.
About Applechem:
Applechem is a leading manufacturer of APIs and pharmaceutical products. We are committed to providing high-quality products and services to our customers, and we are seeking a talented and experienced Quality Assurance and Regulatory Specialist to join our team.
-
Quality Assurance Specialist
4 weeks ago
Reston, Virginia, United States Barrington James Full timeQuality Assurance SpecialistBarrington James is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a crucial role in ensuring the highest standards of product quality, regulatory compliance, and manufacturing processes.Key Responsibilities:Review batch production records,...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Surf Search Full timeQuality Assurance SpecialistSurf Search is seeking a highly skilled Quality Assurance Specialist to join our bio-analytical laboratory client. This role will play a critical part in building our quality organization and ensuring compliance with local, state, and federal regulatory standards.Key Responsibilities:Lead virtual and on-site audits/inspections...
-
Regulatory Affairs and Quality Assurance Leader
2 weeks ago
Reston, Virginia, United States Meet Full timeRegulatory Affairs and Quality Assurance LeaderMeet is seeking a seasoned Regulatory Affairs and Quality Assurance Leader to join our team. As a key member of our organization, you will be responsible for leading the Regulatory Affairs and Quality Assurance functions, managing all aspects of Regulatory submissions, and interacting with FDA and ex-US Health...
-
Quality Assurance Specialist
4 weeks ago
Reston, Virginia, United States Randstad Life Sciences US Full timeJob Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Randstad Life Sciences US. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Lead meetings to facilitate and/or support the Drug Shortage...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Global Recruiters of Dublin (GRN Dublin) Full timeJob Title: Quality Assurance SpecialistGlobal Recruiters of Dublin (GRN Dublin) is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the site's quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.Key...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Medix™ Full timePosition OverviewMedix™ is seeking a highly skilled Quality Assurance Specialist to support the Regulatory and Quality Departments. This role will focus on Statistical Process Control (SPC), Calibration, and Project Management with customers. The successful candidate will develop strategies to enhance customer satisfaction, particularly following audits,...
-
Quality Assurance Specialist
3 weeks ago
Reston, Virginia, United States NOWDiagnostics | NOWDx Full timeJob Title: Quality Assurance SpecialistDepartment: Quality AssuranceReports To: Quality ManagerPosition Summary: The Quality Assurance Specialist plays a critical role in ensuring the quality and compliance of medical devices. This position works closely with cross-functional teams to understand design characteristics and specifications, and performs reviews...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States MS Companies Full timeJob Title: Quality Assurance SpecialistAt MS Companies, we are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the highest quality standards in our products and services.Key Responsibilities:Develop and implement quality plans to ensure compliance with regulatory requirements...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States NOWDiagnostics | NOWDx Full timeJob Title: Quality Assurance SpecialistDepartment: Quality AssuranceReports To: Director of QualityPosition Summary: The Quality Assurance Specialist plays a critical role in ensuring the quality and compliance of our medical devices. This individual will work closely with the engineering team to understand critical design characteristics and perform reviews...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States I3 INFOTEK INC Full timeJob Opportunity: Specialist, Quality Assurance (QA)At I3 INFOTEK INC, we are seeking a highly skilled Quality Assurance Specialist to join our team.Key Responsibilities:Conduct on-the-floor oversight of manufacturing operations to ensure compliance with regulatory and industry standards.Review and approve documentation related to media and buffer...
-
Product Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States BioTalent Full timeJob Title: Quality Assurance SpecialistDescription: At BioTalent, we are seeking a skilled Quality Assurance Specialist to support the development and implementation of quality systems for medical devices. This role will be responsible for ensuring compliance with regulatory requirements, such as FDA QSR and ISO 13485.Responsibilities:Monitor product quality...
-
Quality Assurance Specialist
1 month ago
Reston, Virginia, United States Hyve Solutions Full timeJob Title: Quality Assurance SpecialistHyve Solutions Corporation is seeking a detail-oriented and results-driven Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our products meet the highest quality standards.Key Responsibilities:Review and approve Product and Processes Corrective...
-
Design Quality Assurance Specialist
1 week ago
Reston, Virginia, United States Intellectt Inc Full timeJob Title: Design Quality Assurance SpecialistLocation: Not specifiedDuration: Not specifiedKey Responsibilities:Ensure compliance with IVDR 2017/746 and ISO 13485 regulations.Develop and maintain Design History Files (DHF) and oversee design control processes.Assist in the development and maintenance of records and procedures within the quality management...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Demo - Maximus Full timeJob SummaryMaximus is seeking a highly skilled Quality Assurance Specialist to oversee annual audits and ensure project compliance with corporate and contractual requirements.Key ResponsibilitiesConduct internal audits to identify areas for improvement and ensure compliance with regulatory requirements.Extract, aggregate, review, analyze, and present data in...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Net2Source Inc. Full timeJob Title: Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Net2Source Inc. The successful candidate will be responsible for supporting the Quality Assurance Label Control group, ensuring accurate printed information on labels in compliance with health authority requirements.Key...
-
Quality Assurance Specialist
1 week ago
Reston, Virginia, United States Comprehensive Logistics Co., Inc. Full timeComprehensive Logistics Co., Inc. is a dynamic company that relies on skilled professionals to drive its success. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards in our manufacturing processes.Key responsibilities include:Maintaining quality-assurance processes, testing products, and recording and...
-
Quality Assurance Specialist
3 weeks ago
Reston, Virginia, United States Compunnel Inc. Full timeJob Title: Quality Assurance SpecialistDuration: 6 monthsLocation: Business Unit: EngineeringCategory: QualityJob Summary:The Quality Assurance Specialist supports the organization with quality improvements efforts. Performs quality audit checks, keeps control of quality check consistency, and analyzes the quality audit results.Key Responsibilities:Conducts...
-
Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States GForce Life Sciences Full timeJob Title: Quality Assurance SpecialistAbout the Role:As a Quality Assurance Specialist at GForce Life Sciences, you will play a critical role in ensuring the quality and integrity of our products. You will be responsible for performing quality assurance activities, including reading and understanding SOPs, writing and revising documentation, and supporting...
-
Senior Quality Assurance Specialist
2 weeks ago
Reston, Virginia, United States Astrix Full timeWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Astrix. This is a contract position with a competitive hourly rate of up to $50.Job Summary:The successful candidate will be responsible for managing quality assurance programs, performing audits, and ensuring regulatory adherence. They will also spearhead ongoing...
-
Quality Assurance Label Specialist
2 weeks ago
Reston, Virginia, United States ECLARO Full timeJob Title: Quality Assurance Label SpecialistJob Summary:We are seeking a highly skilled Quality Assurance Label Specialist to join our team at ECLARO. The successful candidate will be responsible for supporting the cGMP Label Control operations, including the coordination, issuance, reconciliation, and management of production labels and records.Key...