Company:
GTT, LLC
Location: Rocklin
Closing Date: 19/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Quality Systems Specialist
Contract Duration 12 Months
Pay range $28 - $30/hr
Location: Rocklin, CA
Work: Onsite
Job Summary:
As a Quality Systems Specialist, you'll play a vital role in ensuring compliance with quality standards and regulations. You'll review and analyze quality documentation, support audits, and contribute to continuous improvement initiatives.
Key Responsibilities:
Document Review: Review and analyze quality documents (e.g., DHFs, technical files, risk management plans) for compliance.
Quality Assurance: Ensure compliance with regulations (ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP) and company quality standards.
Audit Support: Support internal and external audits as required.
Documentation Development: Write, revise, and review Standard Operating Procedures (SOPs).
Training: Train other staff members on quality systems and procedures.
Continuous Improvement: Identify and recommend process improvements.
Compliance: Adhere to regulatory requirements and company policies.
Qualifications:
Experience: Entry-level position, no prior experience required.
Education: High school diploma or equivalent.
Knowledge: Understanding of quality systems and regulations (ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP).
Skills: Strong attention to detail, organizational skills, and analytical abilities.
Work Environment:
Schedule: Regular business hours with potential for overtime.
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About The Company:
Leading research-intensive biopharmaceutical company committed to saving and improving lives. Offers innovative health solutions for the prevention and treatment of diseases. Fosters a diverse and inclusive workplace and operates responsibly for a sustainable future.
Keywords: quality systems specialist, quality assurance, quality control, quality management, regulatory compliance, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, quality documentation, document review, audit support, SOPs, training, continuous improvement, healthcare, medical device, manufacturing, quality engineering, quality analyst, quality auditor, biopharmaceutical, pharmaceuticals, drug discovery, research and development, vaccines, medicine, health solutions, disease prevention, treatment, sustainability, diversity, inclusion, corporate social responsibility
#gttnonit
#gttjobs
(phone number removed)
Quality Systems Specialist
Contract Duration 12 Months
Pay range $28 - $30/hr
Location: Rocklin, CA
Work: Onsite
Job Summary:
As a Quality Systems Specialist, you'll play a vital role in ensuring compliance with quality standards and regulations. You'll review and analyze quality documentation, support audits, and contribute to continuous improvement initiatives.
Key Responsibilities:
Document Review: Review and analyze quality documents (e.g., DHFs, technical files, risk management plans) for compliance.
Quality Assurance: Ensure compliance with regulations (ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP) and company quality standards.
Audit Support: Support internal and external audits as required.
Documentation Development: Write, revise, and review Standard Operating Procedures (SOPs).
Training: Train other staff members on quality systems and procedures.
Continuous Improvement: Identify and recommend process improvements.
Compliance: Adhere to regulatory requirements and company policies.
Qualifications:
Experience: Entry-level position, no prior experience required.
Education: High school diploma or equivalent.
Knowledge: Understanding of quality systems and regulations (ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP).
Skills: Strong attention to detail, organizational skills, and analytical abilities.
Work Environment:
Schedule: Regular business hours with potential for overtime.
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About The Company:
Leading research-intensive biopharmaceutical company committed to saving and improving lives. Offers innovative health solutions for the prevention and treatment of diseases. Fosters a diverse and inclusive workplace and operates responsibly for a sustainable future.
Keywords: quality systems specialist, quality assurance, quality control, quality management, regulatory compliance, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, quality documentation, document review, audit support, SOPs, training, continuous improvement, healthcare, medical device, manufacturing, quality engineering, quality analyst, quality auditor, biopharmaceutical, pharmaceuticals, drug discovery, research and development, vaccines, medicine, health solutions, disease prevention, treatment, sustainability, diversity, inclusion, corporate social responsibility
#gttnonit
#gttjobs
(phone number removed)
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