Quality Assurance Specialist

POSITION: Quality Assurance Specialist

REPORTS TO: Quality Manager

SALARY: Compensation $55,000-$70,000 plus bonus.

TERMS OF EMPLOYMENT: Permanent - Full Time 

LOCATION: Charlottetown, PEI

Island Abbey Nutritionals provides full contract manufacturing, bottling, and packaging services for white-label production from concept to launch.
 
 We are the proud makers of Honibe natural health products- the only pure solid honey products in the world scientifically proven to retain all of honey's naturally occurring health benefit.

The Quality Assurance Specialist assures consistent quality of production by developing and enforcing good quality systems, validating processes, providing documentation and control procedures to build quality parameters to mitigate quality risks.

KEY RESPONSIBILITIES

Quality Assurance Specialist

• Maintain and improve the electronic Quality Management System (eQMS) in line with cGMP including, but not limited to:
  1. Managing change control within the eQMS, ensuring proper workflow execution, approvals, version control, and effective dates.
  2. Provide eQMS administration support, including addressing user inquiries, troubleshooting issues, and facilitating document lifecycle workflows.
  3. Support the implementation, optimization, and maintenance of quality modules and document workflows and lifecycles within the eQMS.
  4. Maintaining controlled quality documentation including customer specifications, internal specifications, labeling documents, and other controlled quality records.
• Lead and maintain the site HACCP plan, including hazard analysis, CCP identification, limits, monitoring and trending, corrective actions, auditing and verification
• Coordinate and ensure all external pest control inspections are scheduled and completed, ensuring all identified deficiencies are escalated to the appropriate departments and all corrective actions are implemented and completed.
• Assist in maintaining Food Safety Management System to ensure food safety at all stages of the operation.
• Assist in managing all aspects of document control for the site's quality programs, including development and implementation of procedures and forms to support quality and food safety systems. Assist in delivering training and orientation materials regarding GMP, HACCP, food safety and related topics
• Ensure compliance with GMP's and SOP's, as well as external regulations.
• Assist in performing QA review of production documentation associated with quality issues, including Quality Events, change controls, discrepancies, and reworks
• Initiate Out of Specification (OOS) investigations as required by internal procedures and reporting OOS results and investigations to the Quality Manager immediately as they occur. 
• Assist with root cause investigation and risk analysis 
• Assist in handling vendor and customer complaint investigations, resolution, and tracking
• Assist in performing QA review of Batch Production Records (BPRs) to support finished goods release 
• Assist in corrective actions program, including identification and verification of corrective actions and monitoring completion and their effectiveness.
• Responsible for application and verification on all logistic regulatory paperwork required for export to all applicable international customers. 
• Assist in developing and conducting programs of sampling and analysis to maintain quality standards of raw and packaging materials, finished products, and environment.
• Coordinate and ensure environmental swabbing and sampling are conducted on time and analyze the data and create trends. Conduct research to determine efficiency and effectiveness of policies and programs
  • Support the approval of new suppliers and new ingredients and maintaining the supplier approval program. 
  • Assist in 3rd party lab for managing raw and finished product, and environmental monitoring activities.
  • Assist in performing internal and supplier audits and fully document root cause analysis and corrective actions for process Quality Events.
  • The position will assist in inspections and audits by regulatory agencies, customers, and third-party agencies.
  • Ensure compliance with product specifications, labeling, and regulatory standards
  • Handle vendor and customer complaint investigations, resolution, and tracking
• Provide regular support to Quality Manager on quality and food safety issues. Performs other duties as assigned.

QUALIFICATIONS

• Bachelor's degree in Food Science, Chemistry, Biology, Nutrition, or related field3+ years QA experience in dietary supplement, pharmaceutical, medical device, food, or related regulated manufacturing industry.
• Knowledge and experience working with cGMP (FDA, HC, NHPR), HACCP, GFSI standards, quality auditing, CAPA, and document control practices would be considered an asset.
• Microbiology knowledge and sampling will be an asset.
• Excellent communication skills written as well as spoken.
• Proficient in the use of Microsoft Office products- excel and power point
• Must be well organized and demonstrate effective time management skills
• High attention to detail.

OTHER

 Must have proof of eligibility to work in Canada

PHYSICAL ASPECTS OF POSITION (INCLUDES BUT IS NOT LIMITED TO):

This position requires the ability to:

• Stand, or walk for an extended period on a hard surface
• Life up to 25 lbs
• Work in a variety of temperatures
• Working with personal protective equipment
• Noise