Sr. Quality Assurance Associate - Paris, Canada - Randstad Canada

Description

Our client is a company that specializes in providing skin care, cleaning, and hygiene solutions for industrial, institutional, and healthcare users.

They have partnered with Randstad Engineering to find their next Senior Quality Assurance Associate, who will be responsible for ensuring compliance with GMP, FDA, and HC regulations.

Title - Sr. Quality Assurance Associate - GMP, FDA, HC Regulations
The position is located in Brantford, ON
The position falls under the GMP/Consumer Products industry.

The Senior Quality Assurance Associate will report to the Quality Supervisor and will be a full-time permanent employee with benefits.

The purpose of the Senior Quality Assurance Associate role is to carry out day-to-day quality assurance and compliance activities.

If you are interested in this role, Please share your resume with me at

Advantages

Benefits:

• Dental care
• Disability insurance
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• Vision care

Schedule:

• 8-hour shift
• Day shift
• Monday to Friday

Job Types:
Full-time, Permanent

Responsibilities

• Prepare paperwork for finished product release (C of A's, release paper).
• Participate in regulatory audits (FDA, Health Canada)
• Review technical documents including packaging orders, batch records, QC testing (bulk, finished product and raw materials), packaging components, stability and validation testing.
• Co-ordinates change control and CAPA activities by assigning change control & CAPA numbers, distributing change controls for review and approval, and following up with the required activities for change control& CAPA closure.
• Work with department managers to ensure the compliant execution of the training program.
• Conduct internal audits and issue reports to management assuring compliance with company SOPs/policies and regulations.
• Conduct deviation investigations, with the aid of involved department personnel, identify the root cause, required corrective action and/or preventative actions.
• Assist in the generation and review of SOPs and associated controlled documents.
• Develop and implement standard operating procedures.
• Monthly documentation review for compliance to quality systems and predefined specifications.
• Issue technical documents such as working batch records and packaging records to production.
• Control and maintain current master indexes.
• Perform inspections and line clearances according to approved manufacturing and packaging records.
• Participates in investigation and follow-up for non-conformances (OOS and OOT).
• Perform and assist in Customer Complaint investigations.
• Initiates Vendor Complaints and follows up on vendor's implementation of corrective actions
• Co-ordinate and organize product launches and documentation-related activities.
• Write Annual Product Quality Reports (APQRs) for product consistency regarding their quality, including deviations, change controls and customer complaints. APQRs are sent to related customers.
• Review and/or approve technical documents (Certificates of Analysis, MWBR, MPO) in the absence of the Supervisor, QA
• Other duties as assigned.

Qualifications

• Minimum Bachelor of Science degree obtained through accredited university with a minimum of 5 years of work experience.
• Quality Assurance experience in a GMP environment

Preferred Experiences And Skills

• Thorough knowledge of applicable regulatory and industrial standards as it relates to cGMP and GLP.
• Ability to organize and manage multiple priorities
• Workplace Hazardous Materials Information Systems (WHMIS) training,
• Organizational skills to handle multiple tasks.
• Strong interpersonal skills required to effectively liaise with manufacturing staff, administration staff and external contacts.
• Good Verbal and written communication skills in dealing/corresponding with outside contacts and internal staff.
• Good judgement and problem solving skills necessary when dealing with results that require modifications/resolving.

Summary
If you are interested in this role, Please share your resume with me at

Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada.

As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees.

In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.

Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle.

We ask that all job applications please identify any accommodation requirements by sending an email to to ensure their ability to fully participate in the interview process.