Job description

About SQ Innovation, Inc.

SQ Innovation, Inc. is a privately held Swiss biopharmaceutical company located in Zug, Switzerland, and Burlington, MA - USA. SQ Innovation was established to develop and commercialize innovative cost-effective therapies for subcutaneous delivery of pharmaceutical products where and when needed. These products are subject to regulatory review and approval. SQ Innovation is currently developing a novel drug-device combination for the cost-effective subcutaneous delivery of diuretics that currently require intravenous administration by a certified healthcare professional. The company is pursuing a 505(b)(2) NDA for the drug-device combination. For more information visit www.sqinnovation.com

Job Overview:

The Document Control Specialist is a member of the Quality team and supports the Organization with document control, records management, and training compliance using ZenQMS. The Document Control Specialist is responsible for reviewing, routing, uploading, archiving, and distributing documents, records, and training assignments. Assists with system validation and configuration. Assists with document preparation and ensuring compliance with procedures. Assists with audits and company meetings as scribe. Ensures training dossiers are current and accurate. Ensures records are organized and maintained for retrievability.

Responsibilities:

• Ensure compliance with Document Control, Change Control, Training, and Records Management processes.
• Provide Document Control guidance, including Change Control, to internal and external personnel or vendors.
• Organize and maintain Design History File, Device Master Record, Device History/Batch Records, and similar records required for regulatory inspection.
• Manage support tickets or product enhancement tickets with eQMS vendor.
• Review and update documents, training, and records per change control.
• Scribe for the organization in any required meetings or environments where capturing the content completely and accurately is vital to the organization’s success.
• Assist with electronic Quality Management System (ZenQMS), Records Management, Training records, electronic signature processes, and related software systems in accordance with effective QMS procedures.
• Assist IT, Business Operations, and Quality with user access, roles, and permissions of the eQMS in collaboration with.
• Assist IT and Quality with ensuring the eQMS remains validated for intended use, including performing or project management of validation/qualification.
• Assist with configuration or revision of workflows in eQMS.
• Assist SMEs and Quality with managing the training matrix, training assignments, performance metrics monitoring, and records.
• Assist Quality with the record retention policy, archives (physical and electronic), and disposition process.

Qualifications:

• Bachelor’s degree or equivalent working experience.
• 2-3 years working in a Quality, Regulatory, Document Control, Training, or Records Management role in a Life science, Medical Device, Pharmaceutical, or similar regulated industry.
• Knowledge of data integrity, good documentation practices, computer system validation, knowledge management or information management, and working knowledge of regulatory requirements/ standards (e.g., 21 CFR Part 4, 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019).
• Attention to detail, effective written and verbal communication skills, and ability to organize/prioritize to meet timelines, and work independently in a fast-paced work environment.

Preferred:

• ISO 13485 or ISO 9001 Lead Auditor or Auditor or ASQ certifications.
• Records management certification.
• Project management certification.
• Technical writing or configuration management experience.

Job Type: Full-time

Pay: $65,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
Employees will be required to provide either proof of vaccination or an approved reasonable accommodation to be exempted from the requirements.

Application Question(s):

• Are you local to Burlington, MA?

Experience:

• eQMS administration: 3 years (Required)
• scribe: 1 year (Required)

Work Location: In person

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