QA Documentation Specialist GMP

Job content

Job description

Established in 1999, Empack Spraytech Inc. is a leading aerosol manufacturer, liquid filler, and custom contract packager. Located in Brampton, Empack manufactures products for a wide range of markets including personal care, household goods, automotive, computer care, industrial and outdoors. We offer private label programs and produce a range of products under our house brands that include emzone, zytec Germ Buster, and SunZone.

Quality Assurance (QA) Documentation Specialist GMP – Brampton, Ontario

What you will need to be successful:

• Post-secondary degree in Quality Control, Quality Assurance, Chemistry, or a Health Canada recognized Science related BSc. Degree will be a mandatory requirement for this position
• A minimum of 3 years of process controls, document management, and quality experience.
• 3 plus years of work experience in a GMP regulated industry (Pharmaceutical, Food, Consumer product or Personal Care Product manufacturing setting in Technical or Production functions).
• Ability to troubleshoot and resolve minor issues.
• Capable of working at a consistently fast pace.
• Excellent English written and verbal communication skills.
• Accuracy with a high attention-to-detail.
• Ability to multi-task in high-pressure environments
• Experience with Microsoft Office Word and Excel is required.
• Ability to multi-task, prioritize, and manage time effectively.

What you will do:

1. Maintain GMP related paper and electronic records, documents, and files:

· Control the Master and Archiving System of all Formulas & Packaging Files for current or obsolete revisions

· Document NCR`s and CAPA’s and participate in the evaluation and Action Plan follow up.

2. Finished Product Release –

· Review Batch master files to ensure 100% completion and compliance with GDP.

· Identify and correct and non-conformances found

· Maintain a soft copy archiving system for the Batch master file up to date.

· Perform yield calculations and investigate any out of limit findings.

· Archive executed manufacturing batch documents according to the current Revision of SOP QA-140

3. Incoming Packaging Componentry Inspection, Testing, Release and Re-conciliation

· Coordinate with internal department to ensure compliance with SOP and to ensure the proactive testing and release of components in time for production schedule.

· Coordinate external labs testing requests and release components once results received.

· Create and control reconciling system for all DIN Packaging components

· Coordinate with Online QA auditors for reconciliation and matching the records.

4. Overseeing Facility Monitoring Systems

· Maintain QA Scale, Gauges & Instruments calibration program (GMP & Industrial) including co-ordination of calibrations with external service providers.

5. Assist and aid in the coordination and sign off:

· Compilation of supporting documents for GMP audits and corresponding response requirements

· Support in the compilation of data and reports for Annual Product Reviews

· GMP mandated special event activities

Empack Spraytech Inc. is committed to the core values of equal employment. We are committed to treating people fairly, and with respect and dignity. We offer employment opportunities based on an individual’s qualifications and experience, free from discrimination or harassment due to race, ancestry, place of origin, ethnic origin, colour, citizenship, creed, gender, sexual orientation, age, marital status, family status, disability, and any other legally protected class in accordance with applicable federal, provincial, and local laws. Empack Spraytech Inc. is committed to creating and maintaining an inclusive workplace. Applicants should advise Human Resources if they require any type of accommodation during the recruitment process.

Job Types: Full-time, Permanent

Salary: $58,000.00-$61,000.00 per year

Benefits:

• Dental care
• Extended health care
• Life insurance
• Paid time off
• Vision care

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
Masks and Social Distancing

Education:

• Bachelor’s Degree (required)

Experience:

• GMP: 2 years (preferred)
• Quality assurance: 3 years (preferred)
• QMS: 2 years (preferred)

Work Location: In person

Application deadline: 2023-08-13
Expected start date: 2023-08-14