Title:  QA Compliance Associate

Job Title:

QA Compliance Associate

Job Grade:

G11B/G11A

Department:

Quality Assurance

FLSA Classification:

Exempt

Manager’s Job Title:

Senior Manager, NAM Center of Excellence

Department Head Title:

North America Quality Cluster Head

Job Summary

Responsible for working with the North America Sites Quality team (Ohm, Billerica, SPCI) for preparation, review, trend, monitor quality related activities and documents.  This individual shall perform multiple assignments simultaneously while working independently, with site stakeholders as appropriate.

Area Of Responsibility

• Collation of data and drafting the Annual Product Reviews
• Work with North America manufacturing sites to help complete the Product Quality Complaint records in TrackWise System.
• Collate and prepare PQC trend reports for products and trending on defined frequency as per SOP.
• Perform gap assessments of site SOPs vis-à-vis the global documents and derive actions required for revision of site SOPs.
• Support the North America sites for routine revision of SOPs.
• Support the North America site in assessment and mitigation of global actions in a timely manner.
• Perform assessment and review of annual batches on stability for batches manufactured at different sites and imported by Sun Canada for distribution in Canada market.
• Any additional work assigned by the reporting manager to support North America Cluster.

Work Conditions:

Corporate Office Environment

Manufacturing / Production Environment

Laboratories

Physical Requirements:

• Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.
• Must be capable of bending and lifting, moving and/or carrying up to approximately 50 pounds.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate

Up to 10  %

Education and Job Qualification

• Minimum of Master’s degree preferred.
• Role supporting seminars and courses are an asset.
• Thorough understanding of GMPs, specifically those relating to good documentation practices, quality management system, complaint handling, etc.
• Ability to work effectively in an international multicultural matrix organization
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, TrackWise, Document Management System, LMS (Learning Management System) etc.
• Strong communication, interpersonal and organizational skills
• Fluency in English language will be required.

Experience

• Minimum of five (5) years of experience within the pharmaceutical industry

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).