Documentation Specialist I

PSG Global Solutions; Regina; On-site; CAD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a Documentation Specialist I to join their dynamic team in the Pharmaceuticals and Medical Products sector. This role is pivotal in managing product complaints, ensuring quality assurance, and developing standard operating procedures (SOPs) to maintain compliance with regulatory standards. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with a keen eye for detail and a commitment to excellence. If you are passionate about contributing to the quality of pharmaceutical products and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• Experience in Quality Assurance and regulatory compliance in pharmaceuticals.
• Ability to develop and review SOPs and production batch records.

Responsibilities

• Manage product complaints and review production batch records.
• Develop SOPs and ensure compliance with GMP guidelines.

Skills

Quality Assurance

Regulatory Compliance

SOP Development

Data Analysis

Education

Bachelor's Degree in Life Sciences

Relevant Certification in Quality Assurance

Tools

Quality Management Systems

Statistical Analysis Software

Job description

Description

We're looking for a Documentation Specialist I, working in the Pharmaceuticals and Medical Products industry at 1 Research Drive, Westborough, Massachusetts, 01581, United States.

Job Description:

• Manage product complaints.
• Review and release production batch records.
• Review and manage change controls.
• Provide Quality Review and approval of deviations related to Manufacturing Equipment, Facility, and production.
• Participate on a team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.
• Report metrics and create monthly and quarterly reports.
• Develop SOPs as required.
• Perform in accordance with SOPs, safety, and GMP guidelines to support the release of finished products.
• Maintain and increase scientific, regulatory, and compliance expertise and work with the existing QA group to develop organizational and technical capabilities.
• Be current with various regulatory requirements and procedures.