Quality Specialist

Quality Specialist

CooperSurgical, Inc. 

Canada 

Summary:

The Quality Specialist is responsible for assisting with the development, implementation and maintenance of the Quality Systems for the biorepository and its processes and activities that ensure compliance with all relevant regulatory and accrediting bodies. This position reports to the Quality and Regulatory Manager

Essential Responsibilities and Duties include the following. Other duties may be assigned.

• Maintains key areas of the Quality Assurance program such as: Document Control o Internal Audits, Quality Meeting Minutes preparation and distribution, QC Tracking for Shipping
• Is part of the Quality Team and provides support in the execution of the company’s quality program.
• Reviews and monitors all standards and guidelines for accrediting bodies and regulatory agencies such as Health Canada, AABB, and FACT. Shares information with staff and Directors and provides suggestions to improve the quality program on an ongoing basis
• Chairs all quality meetings with responsibility for bringing QC reports and Deviances and Non-conformances.
• Ensures Master Document List and SOP’s are maintained and documents are reviewed in a timely manner.
• Conducts and reports on internal audits
• Ensuring adequate validation of new and changed processes

Education, training and experience: 

• Post Secondary level education (BSc or higher) in a relevant discipline from a recognized academic institution.
• At least 2 years experience in Cell Therapy, Tissue or Pharmaceutical environment is required.
• Experience with GLP, GMP or Quality Systems is desired.
• Relevant experience with Health Canada, FDA, AABB, ISOor FACT is desired.
• A Certificate in Quality Control/ Assurance is desired.
• Ability to function effectively in a highly regulated environment in an evolving industry.
• Ability to anticipate quality issues and manage through to resolution in a proactive manner.
• Demonstrated analytical, problem-solving and decision-making skills.
• Strong communication, impact and influencing skills.
• Attendance to Conferences/travel may be required.

General Competencies

• Core Cryolab is a quality based company and all employees are expected to be
• trained, competent and to conduct their work according to the policies, processes
• and procedures in place.
• Analytical - Synthesizes complex or diverse information; Collects and researches data;
• Designs work flows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations
• Technical Skills - Assesses own strengths and weaknesses; Strives to continuously build knowledge and skills; Shares expertise with others.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity an openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Quality Management - Demonstrates accuracy and thoroughness.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Planning/Organizing - Prioritizes and plans work activities; Meets productivity standards; Completes work in timely manner; Monitors own work to ensure quality.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions ; Uses equipment and materials properly.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are communicated when absent; Arrives at meetings and appointments on time.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; pursues opportunities for improvements