Document Control Analyst II
Noctrix Health Noctrix Health Pleasanton, CA Pleasanton, CA Full-time Full-time $75,000 - $110,000 a year $75,000 - $110,000 a year The Document Control Analysts II at Noctrix Health is responsible for ensuring the Noctrix Health Document Control System is managed in compliance with Noctrix Health's SOPs.
The Document Control Analysts II will be based at Noctrix Health's Pleasanton, CA location.
This position is responsible for managing and administering the Noctrix eQMS Document Control systems to ensure compliance to applicable internal procedures, medical device GMPs, and regulatory requirements.
This position will also be responsible for managing and maintaining the Noctrix Health training program related to the controlled documents and internal training.
Additional functions include QA support for change control, document control, training, eQMS validation, audits, and regulatory inspections.
This position reports to Sr.
Director Quality Assurance FUNCTIONS Serves as primary Document Control/eQMS administrator Works independently to manage and administer effective Document Control systems ensuring compliance to applicable internal procedures and applicable regulatory requirements Works with QA Director to establish and execute Document Control Procedures Supports update, review, and approval of controlled documents, including standard operating procedures, standard test methods, protocols, reports, and technical documents according to specific approved formats Creates and maintains document templates as needed Ensures controlled documents conform with applicable procedures, reviews formats for consistency Supports controlled document life cycle/retention procedures Manages employee training program and periodic review of all electronic training files Updates Training Matrices for all GMP employees; creates and maintains electronic employee training files; assists with group training Assists with Supplier Management Program - maintains database and tracks due dates for audit reports, supplier re-assessments Manages Records Retention/Archiving, ensuring adherence to record retention schedules Writes QMS SOPs related to document control/document management and other QMS areas as needed Assists with audits and regulatory inspections Provides cross-functional support within QA department, as needed Perform other QA related duties as assigned by QA Director Follows Noctrix procedures, policies, and applicable regulations REQUIREMENTS Associates Degree or equivalent Three to five years' experience in document processing/document management in a medical device or pharmaceutical company.
Experience in Document Control, CAPA, Change Control, and Training systems Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word.
Excel, PowerPoint, One Drive, Microsoft Teams Knowledge of ISO standards FDA regulations and industry standard guidelines including ISO 13485, 21 CFR 820, 21 CFR Part 11 Team player with strong attention to detail Interpersonal skills - ability to interact well with colleagues at all levels Adapts to changing priorities effectively Ability to work independently on assignments Good problem-solving skills Must be able to lift up to 20 lbs.
at a time.
Must be able to sit for prolonged periods of time at a desk working at a computer.
Job Type:
Full-time Pay:
$75,000.
00 - $110,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
8 hour shift Supplemental pay types:
Bonus pay Ability to commute/relocate:
Pleasanton, CA 94566:
Reliably commute or planning to relocate before starting work (Required) Application Question(s):
Have you been responsible for Document control at a medical device company? Have you worked with the Arena Quality Management Software?
Experience:
experience in medical device company for more than 2 years.
(Required) Work Location:
Hybrid remote in Pleasanton, CA 94566.
Estimated Salary: $20 to $28 per hour based on qualifications.
The Document Control Analysts II will be based at Noctrix Health's Pleasanton, CA location.
This position is responsible for managing and administering the Noctrix eQMS Document Control systems to ensure compliance to applicable internal procedures, medical device GMPs, and regulatory requirements.
This position will also be responsible for managing and maintaining the Noctrix Health training program related to the controlled documents and internal training.
Additional functions include QA support for change control, document control, training, eQMS validation, audits, and regulatory inspections.
This position reports to Sr.
Director Quality Assurance FUNCTIONS Serves as primary Document Control/eQMS administrator Works independently to manage and administer effective Document Control systems ensuring compliance to applicable internal procedures and applicable regulatory requirements Works with QA Director to establish and execute Document Control Procedures Supports update, review, and approval of controlled documents, including standard operating procedures, standard test methods, protocols, reports, and technical documents according to specific approved formats Creates and maintains document templates as needed Ensures controlled documents conform with applicable procedures, reviews formats for consistency Supports controlled document life cycle/retention procedures Manages employee training program and periodic review of all electronic training files Updates Training Matrices for all GMP employees; creates and maintains electronic employee training files; assists with group training Assists with Supplier Management Program - maintains database and tracks due dates for audit reports, supplier re-assessments Manages Records Retention/Archiving, ensuring adherence to record retention schedules Writes QMS SOPs related to document control/document management and other QMS areas as needed Assists with audits and regulatory inspections Provides cross-functional support within QA department, as needed Perform other QA related duties as assigned by QA Director Follows Noctrix procedures, policies, and applicable regulations REQUIREMENTS Associates Degree or equivalent Three to five years' experience in document processing/document management in a medical device or pharmaceutical company.
Experience in Document Control, CAPA, Change Control, and Training systems Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word.
Excel, PowerPoint, One Drive, Microsoft Teams Knowledge of ISO standards FDA regulations and industry standard guidelines including ISO 13485, 21 CFR 820, 21 CFR Part 11 Team player with strong attention to detail Interpersonal skills - ability to interact well with colleagues at all levels Adapts to changing priorities effectively Ability to work independently on assignments Good problem-solving skills Must be able to lift up to 20 lbs.
at a time.
Must be able to sit for prolonged periods of time at a desk working at a computer.
Job Type:
Full-time Pay:
$75,000.
00 - $110,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
8 hour shift Supplemental pay types:
Bonus pay Ability to commute/relocate:
Pleasanton, CA 94566:
Reliably commute or planning to relocate before starting work (Required) Application Question(s):
Have you been responsible for Document control at a medical device company? Have you worked with the Arena Quality Management Software?
Experience:
experience in medical device company for more than 2 years.
(Required) Work Location:
Hybrid remote in Pleasanton, CA 94566.
Estimated Salary: $20 to $28 per hour based on qualifications.
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