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DNA Genotek: Capa Writer

DNA Genotek

This is a Full-time position in Ottawa, ON posted February 13, 2021.

OverviewInitiates and facilitates quality assurance records pertaining to Nonconformance and CAPA reporting.

Supports and assists DNA Genotek cross-functional team members in completing documentation of investigations and action plans in a timely manner.

Supports and assists cross-functional team members in driving Nonconformance Reports (NCRs) and CAPA records to closure.

Ensures that all quality investigations meet regulatory requirements.

Responsible for supporting the preparation, analysis, reporting and communication of NCR/CAPA system metrics to Executive Management.

Supports external and customer audits as needed.ResponsibilitiesSupports timely and thorough investigation of nonconformancesInitiates and manages CAPA records on behalf of, and in concert with, process owners throughout the organization, as needed Supports DNA Genotek cross-functional teammates and provide guidance on how to document and manage CAPA activities.

Supports and assists in data collection/entry, root cause analysis, and closure of investigations Supports and assists in appropriate entry of CAPA information into the SAP CAPA system Supports CAPA record completion to established timelines.

Supports timely closure of CAPAs in SAP Supports and assists cross-functional team members in timely completion of complaint investigations per regulatory requirements, as needed Supports and assists the DNA Genotek CAPA Specialist in providing training to the NCR and CAPA Program Assists in the preparation of reports and communicates NCR, CAPA and Planned Deviation metrics to management within the organization, as needed Supports and assists in hosting CAPA Review Board (CRB) Meetings.

Collects data and prepares metrics for these meetings, captures meeting minutes and action items.

Acts as back-up to the DNA Genotek CAPA Specialist on these efforts.

Supports controlled revision to NCR and CAPA quality system documents (i.E.

procedures).

Supports internal and external audits as needed.

Supports other QA activities as directed Quality Assurance Management as needed QualificationsEDUCATION:Degree, diploma, certification or an equivalent combination of relevant job experience, training and knowledge in a Quality Assurance and/or Complaints Management discipline.Recognized Quality Management System certifications such as ASQ CQA, CQIA, CQPA, and CQE are an asset.

EXPERIENCE:Minimum of 2 years in a Quality Assurance role, a CAPA role is preferred Experience and working knowledge of regulatory and industry standard requirements, e.G.

ISO 9001, 13485, and 21 CFR Part 820 Strong working knowledge of, and experience with, nonconformance reportingStrong working knowledge of, and experience with, CAPA management Knowledge of, and experience with, quality metric preparation Strong knowledge of, and considerable experience with, investigatory tools and methodologies Strong verbal and written communication skills Exceptional interpersonal skills Exceptional ability to multitask, prioritize work, and deliver to tight timelines; must be action and results oriented Ability to work independently with minimal supervision and be self-directed.

Ability to influence others in order to get things done, even without direct authority.

Ability to communicate to cross-functional teams.

Well-developed PC skills, i.E.

knowledge of Microsoft applications (Excel, Access, etc.) or equivalent required.

Direct or indirect experience with quality audits/regulatory inspections is highly desired.CORE REQUIREMENTS: Organized Dependable Reliable EnthusiasticMotivated Integrity Positive Analytical Prepared Methodical Results-orientedAt DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.

Accommodations are available to support prospective employees during the recruitment and hiring process.

Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.