Quality Assurance Compliance Associate; Day Shift

Position: Quality Assurance Compliance Associate (Day Shift)
Job Title:

QA Assurance Compliance Associate,

Location:

Cambridge, ON, Position Type:
Full-time Regular,

Shift: Day Shift, Monday - Friday, 6:30am-3:00pm, Vacancy Status:
This role will be vacant, AI Disclosure in Hiring:
We do not use artificial intelligence to screen, assess, or select applicants.

Job Summary
Reporting to the QA Compliance Associate, this role will work within an established culture of quality assurance and continuous improvement in all GMP areas. This role will be directly involved in all areas of quality assurance, including change controls, Annual Product Reviews (APRs), review of technical documents, deviation resolution, managing CAPAs, and ensuring GMP standards are met. In addition, the role will participate in handling customer complaints and inquiries of the products.

This role will include coaching and training operators and supervisors on proper documentation practices and on cGMP requirements.

Key Role Specific Requirements

Conducting annual product reviews by reviewing all production documentation and summarizing key issues and preparing final reports on the quality of the product manufactured.

Assessing potential impact of incidents and processing deviations on the quality and suitability of the product for sale. Includes conducting batch record review and determining batch status, e.g., release, reject or product hold for further clarification or investigation.

Providing oversight and quality assurance approval to various systems (CAPA, deviation, change requests) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented, and consistently managed.

Investigating both individually and as a team member, product complaints, deviations, and out of specification results to determine product impact, root cause and corrective/preventative actions.

Monitoring quality assurance systems and advising/presenting to executive team on system performance; publishing metrics/reports regarding performance against set goals.

Lead change control initiatives and facilitate documentation updates utilizing Microsoft Word and ZenQMS software.

Performing internal quality audits that are compliant with corporate policies, practices, and procedures.

Collaborating with client-facing quality representatives to ensure full customer satisfaction with the company’s products and services.

Providing support to other functions of Quality Assurance department which includes but not limited to the preparation of master documents and the coordination of documentation services through other departments.

Promoting and advocating quality achievement and performance improvement across the organization.

Ensuring ongoing compliance with local, national, and international standards and legislation.

Participating in HPRA, FDA & client audits and ensuring corrective actions are completed as required.

Creating and maintaining QA control documentation.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role
FOSTERING COLLABORATION/TEAMWORK – is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION - is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others.

Express oneself clearly in verbal and business writing.

E…