Quality Systems Documentation Associate (12 month contract)

Position: Quality Systems Associate - Documentation

Department: Quality (Quality Systems)

Job Type: 12-month Contract (Parental Leave Replacement)

Location: Oakville, Ontario

Reporting To: Manager, Quality Systems

Reporting to the Manager, the Quality Systems Associate will be responsible for providing day-to-day operational, and administrative support to the Quality team (QA, QC, Lab Systems, Lab Compliance) and all other GxP departments. This role is primarily on-site with a focus on the support of on-site GxP operations. This role will also require data entry experience, great attention to detail, and excellent self-management skills.

Areas of Responsibility:

• Manage day-to-day administration of the Document Management System to progress GxP documentation through the revision process including, but not limited to document check-in/check-out, setup and launch of document review and approval workflows, tracking document progression through review and approval workflows, following up with document authors, reviewers, and approvers to complete tasks
• Support the site training program and assist in training employees as required
• Manage batch upload of new GxP documentation types into the document management system
• Issue forms, logbooks, and laboratory notebooks to employees upon request
• Liaise with the eQMS system administrator and eQMS vendor to resolve technical support tickets
• Maintain inventory of all archived GxP documentation including receipt of archived documents from internal customers, logging and filing archived documents in the Document Archive Room, transfer of archived documents to the third-party (off-site) document archival location, and destruction of documentation of the end of the retention period
• Maintain the document archive tracker on an ongoing basis
• Manage training folders in an inspection-ready state
• Generate, process, and analyze data to support Quality Systems metrics
• Work with cross-departmental teams to promote quality across the business
• Other duties as assigned.

Qualifications

• Minimum bachelor’s degree in science (Chemistry or Life Sciences) or equivalent experience
• Practical experience in the pharmaceutical industry in the areas of QA or Quality Compliance is preferred.
• Experience working in a pharmaceutical quality systems environment (i.e. employee training and document management etc.) is an asset
• Experience with Good Documentation Practices and Canadian GMP’s and Quality Systems; experience with US FDA cGMP’s an asset
• Ability to work with changing priorities that involve multiple and concurrent projects.
• Strong data entry skills with great attention to detail.
• Well-developed organizational and planning skills.
• Ability to explain ideas logically and concisely.
• Excellent oral and written communication skills.
• Proficient computer skills, including MS Office applications, especially Microsoft Word and Excel.
• Prior experience using a Quality Management System or other business intelligence systems is an asset.
• Ability to accept responsibility and work with minimal supervision.

SteriMax is an equal opportunity employer that is committed to fair and accessible employment practices for all existing staff and potential candidates. Please advise Human Resources if you require an accommodation to participate in the recruitment process

AGENCY NOTICE: Please note that SteriMax does not accept unsolicited resumes from recruiters or employment agencies unless we invite in writing selected recruitment agencies to participate in specifically named recruitment projects. SteriMax will not consider any referrals or agree to payment of referral or recruitment fees. In the event, a recruiter or an agency submits a resume or candidate without a previously signed agreement and a written invitation, SteriMax explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.