QA Specialist - A/QPIC

Medisca • Richmond, BC

2h • Onsite

About The Position

The primary purpose of the A/QPIC – QA Specialist is to fulfill day-to-day activities involving controlled substances as well as day-to-day activities pertaining to quality assurance. The position performs activities involving narcotics and controlled substances in terms of receiving, inventory, shipping, and reporting to ensure compliance with controlled substance regulations. The position also performs activities related to Quality Events, Quarantines, Rejections, Returns as well as any other Quality Assurance-related activites to ensure compliance with GMP. This individual is expected to work in a team environment and independently to meet defined objectives based on established timelines and deliver project work in a manner that is consistent with the company’s values.

Requirements

• Minimum B.S. Degree or equivalent in Life-science or related field
• Working knowledge of regulations required (cGMP, 21 CFR PART 11 and 211, ICH Q7, GUI 0104, GAMP 5, NCR)
• Experience with quality systems including change control, risk assessment and management, incident management, and deviation management
• Strong attention to detail as well as analytical & problem solving skills
• Self-motivated and quick learner of processes and technologies
• Ability to multitask and manage/prioritize multiple projects and deadlines with high accuracy
• Excellent technical writing and communication skills
• Able to work well both independently and collaborate with others
• Excellent communication skills; fluent English (oral & written) required

Nice To Haves

• Previous designation/experience as QPIC or A/QPIC is considered an asset
• Experience in a cGMP environment is considered an asset
• Knowledge of Microsoft Office (Word, Excel), Syspro and MasterControl is considered an asset

Responsibilities

• Process Outbound Controlled Substance orders as per SOP
• Verify and process order information
• Pick and pack the correct product with accuracy
• Select appropriate courier and ship the order with accuracy
• File and retain relevant documents
• Process Inbound Controlled Substance orders as per SOP
• Review and initiate replenishment orders for Controlled Substances
• Inspect incoming packages of Controlled Substances for damage or tampering
• Verify the goods to ensure accurate identity and quantity against the original order sheet
• Perform monthly and year-end inventory count of Controlled Substances
• Prepare monthly activity reports of Controlled Substances
• Prepare Loss and Theft reports (when applicable)
• Complete periodic security checks
• Collaborate and ensure adequacy of SOPs and Quality-related documentation
• Initiate Quality Events as per SOPs to ensure compliance with GMP and regulations
• Perform Quality functions as such Quarantine, Rejection, Inspection to assist in investigations
• Maintain system information such as Code set-ups, BOMs, specs, etc
• Support calibration and monitoring activities of the Temperature/Humidity Environmental Monitoring System
• Support validation activities, as applicable

Benefits

• PTO and vacation policy
• Choice of modular plans, health spending account and free Telemedicine
• Opportunities to learn and grow within Medisca
• Medisca contributes to a deferred profit sharing plan (DPSP) when you invest in RRSPs
• Employee Referral Program
• company events throughout the year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level