10 Nov
|
InGenesis
|
Charlottetown
10 Nov
InGenesis
Charlottetown
Quality Control Technician
Job Details
Professional Discipline :
Admin/Clerical Support
Specialty :
Administration Manager
Employment Type :
Full Time
City :
Charlottetown
State :
PE
Pay Range :
65,000 - 70,000
Job Description:
InGenesis is currently seeking a dedicated Quality Control Technician to work with our client. In this role, you will will be responsible for performing Work in Process (WIP) testing of antigens and batch release testing in accordance with approved Outlines of Production and Good Manufacturing Practices (GMP). The Quality Control Technician is also responsible for stability testing, environmental and utility monitoring, and supporting qualification and validation activities as required.
This position also supports compliance with applicable EU GMP requirements as delegated by the Site Quality Head.
Key Responsibilities
Good Manufacturing Practices (GMP)
- Perform product testing and other Quality Control activities as assigned by management and within the scope of training and job responsibilities.
- Complete testing activities independently or under supervision while in training.
- Conduct peer reviews and approvals of testing records and results, including product testing and environmental/utilities monitoring, as authorized through training and oversight.
- Comply with all applicable GMP regulations and site quality requirements.
- Successfully complete required medical assessments in accordance with GMP regulations and site policies.
Quality Control Operations
- Perform all Work in Process (WIP) and final product batch release testing in accordance with approved Outlines of Production and GMP requirements.
- Execute laboratory methods that include, but are not limited to:
- Microbiology techniques
- Cell culture techniques
- Molecular biology methods
- Perform environmental monitoring (EM) and utility testing for all departments.
- Conduct stability testing activities and maintain associated documentation.
- Support qualification and validation projects, including:
- Equipment validations
- Method validations
- Create,
maintain, and update Standard Operating Procedures (SOPs), Standard Operating documents (SOs), Manufacturing Data Forms (MDFs), and related records.
- Identify and report Out of Specification (OOS) results, deviations, and quality events to the QC Manager.
- Initiate and complete investigations when required.
- Communicate testing results and quality findings with Production and other cross-functional departments.
- Participate in occasional after-hours support and on-call scheduling, as needed.
- Work effectively within all established Quality Management Systems.
Laboratory and Inventory Management
- Perform laboratory cleaning and housekeeping duties.
- Maintain reagent inventory and monitor expiration dates of materials.
- Prepare culture media, agars, and laboratory reagents.
- Clean, sanitize, and manage laboratory glassware.
- Prepare shopping carts and purchase orders.
- Track laboratory supply orders and deliveries.
- Review, manage, and approve invoices as required.
- Perform expiry dating and labeling of newly received materials.
- Maintain and update storeroom inventory records.
Stability and Sample Management
- Receive, store, inspect, submit, and manage stability and retention samples.
- Maintain stability sample pull schedules and testing schedules.
- Create and execute testing and validation protocols.
- Compile and report Quality Control monthly metrics.
- Perform other duties as assigned.
Qualifications
- Bachelor of Science or Technical Diploma (Biotech or Lab technologist)
- Two (2) years of lab experience, GMP training
- Advanced analytical and time management skills
- Excellent problem-solving skills.
- Communications and decision-making skills
Working Conditions
- Laboratory-based role in a GMP-regulated environment.
- Occasional after-hours work and participation in an on-call schedule may be required.
- Medical assessment may be required in accordance with regulatory and site requirements.
EEO Statement:
InGenesis is an equal chance employer committed to fostering a diverse, inclusive, and equitable workplace. We comply with all applicable federal, state, and local employment laws, including recent executive orders, and strictly prohibit discrimination, harassment, or retaliation based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, age, veteran status, or any other characteristic protected by law.
InGenesis is dedicated to making reasonable accommodations for qualified individuals with disabilities and ensuring that all employment decisions are based on qualifications, merit, and business needs. If you require a reasonable accommodation during the hiring process, please contact us by visiting our website at https://www.ingenesis.com/careers/site-accommodations.
To learn more about your rights, please refer to the Know Your Rights: Workplace Discrimination is Illegal poster issued by the U.S. Equal Employment Opportunity Commission (EEOC).
Company Statement:
With decades of experience, InGenesis has grown into one of North America’s most trusted Healthcare Services Firms, which includes comprehensive health and workforce solutions. As the industry landscape shifts with new challenges in patient care, quality and compliance requirements, workforce retention, and operational efficiencies, we deliver strategic, data-driven solutions that include redefining workforce management and clinical service delivery. Explore InGenesis to discover how our expertise, creative strategies, and commitment to excellence are shaping the future of healthcare workforce solutions. Join us in celebrating the professionals who define the next era of healthcare.
📌 Quality Control Technician (Charlottetown)
🏢 InGenesis
📍 Charlottetown