CrawlJobs Logo

Quality Specialist, Product Release

https://www.baxter.com/ Logo

Baxter

Location Icon

Location:
Canada , Mississauga

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

72080.00 - 108120.00 CAD / Year
Save Job
Save Icon
Apply Position

Job Description:

The Quality Specialist (12-month assignment) is responsible for supporting the major Quality Systems and ensure a state of compliance and continuous improvement with product release, annual compliance, field actions/product holds, training and change control.

Job Responsibility:

  • Review laboratory, transportation, and warehouse documentation to ensure product release
  • Disposition of both imported and domestic products
  • Work together with 3PL and internal teams on matters and steps related to product distribution in Canada
  • Manage and maintain all quality documents
  • Conduct impact assessments and complete tasks for change controls
  • Review and approve compliance documentation such as APQR, batch records, and stability data
  • Support method transfers and the launch of new products as required
  • Assist with product holds and quality assessments of returned products
  • Participate in internal audits and regulatory inspections to ensure compliance

Requirements:

  • University Degree or equivalent experience and/or relevant post-secondary education and experience
  • Drug and/or medical device product release/product disposition experience
  • Excellent knowledge of GMPs and Health Canada regulations
  • Strong communication and technical writing skills
  • Ability to take initiative and multitask across projects
  • Experience with third-party logistics and quality frameworks such as NCR/CAPA, Change Control, and Documentation
  • Skills in MS Office and Windows operating systems

Nice to have:

  • University Degree in Sciences/Health Sciences or equivalent experience, supplemented by further post-graduate education
  • Experience in Pharmaceutical Quality Assurance, Chemistry, Biology, or Engineering
  • Prior experience with Corporate and/or MoH audits
  • Strong understanding of Health Canada GMP & Medical Device Regulations
  • Project Management experience
  • Decision-making skills for ambiguous situations and customer focus
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
February 21, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Baxter - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 2204 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Quality Specialist, Product Release

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...
Location
Location
Poland , Warsaw
Salary
Salary:
Not provided
theramex.com Logo
Theramex
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience working in Quality Function within the Pharmaceutical industry
  • Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
  • Basic Knowledge of the Pharmaceutical GxP regulations
  • Able to foster strong cross-functional relationships
  • Influence, interpersonal, verbal, and written communication skills
  • Able to respond positively to, and effectively implement, change
  • Digitally Savvy
  • Fluency in both English and Polish to handle communication with healthcare authorities in Poland
  • A degree or equivalent in a relevant scientific subject is desirable
Job Responsibility
Job Responsibility
  • Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
  • Batch Review all MIA Products Prior to QP Certification
  • Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
  • Investigation and resolution of complaints with CMOs
  • Determining and implementing robust CAPAs as required
  • Assessment and approval of deviations
  • Managing and approval of change controls
  • Creation and Maintenance of Quality / Technical Agreements
  • Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
  • Support of on-site audits and visits
Read More
Arrow Right

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications
Location
Location
United States , Fort Pierce
Salary
Salary:
Not provided
assessfirst.com Logo
Assessfirst
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma, GED or equivalent required
  • Associates degree preferred or a minimum of (3) three to (6) six months quality or plasma industry experience required
  • Strong verbal and written communication skills
  • Must have above average problem-solving and decision-making abilities
  • Proficiency with computers
  • Must have explicit attention to detail
  • Must have excellent analytical skills, organization skills, and follow-up
  • Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals
  • Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
  • Use hands to handle or feel objects, tools, or controls
Job Responsibility
Job Responsibility
  • Perform donor record file review
  • Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual
  • Review medical reports and communication
  • Perform reviews of equipment incidents
  • Verification and release of sample shipment
  • Responsible for the inspection and release of incoming supplies
  • Initiate deviation reports as needed
  • Perform Weekly employee observations
  • Assist the Manager of Quality Assurance with compliance of all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), Occupational Safety and Health Administration (OSHA), and internal company procedures
  • Reviews the documentation of unsuitable test results and the disposition of the associated units
  • Fulltime
Read More
Arrow Right

Quality Assurance Packaging Specialist

This position within the QA department provides Quality oversight, support and k...
Location
Location
Ireland , Cork
Salary
Salary:
Not provided
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree or 3rd level qualification (Science, Quality)
  • Demonstrated experience in packaging as the Quality contact for the area
  • Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role
  • Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  • Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels
  • Strong organizational skills, including ability to follow assignments through to completion
  • Proficiency in PC skills such as Excel, Word, PowerPoint
  • Proven decision making capability with full accountability and responsibility
  • Demonstrated coaching skills
Job Responsibility
Job Responsibility
  • Provide Quality input and guidance to ensure packaging of high quality products in compliance with current Good Manufacturing Practices (GMPs)
  • Provide Quality direction and oversight of the development of new and existing processes in the packaging area to meet customer needs
  • Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections within the packaging area of operations
  • Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely
  • Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
  • Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements
  • Minimising impact to packaging operations on site
  • Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements
  • Review and release inputs for use in manufacturing as required
  • Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies
  • Fulltime
Read More
Arrow Right

Qa specialist

Responsible for executing the food safety and quality strategy for the Specialty...
Location
Location
Netherlands , Amsterdam
Salary
Salary:
Not provided
adm.com Logo
ADM
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in food technology, Quality Management, or related field
  • 3+ years of experience in quality management in the food industry
  • Strong knowledge of food safety standards and quality systems (HACCP, GMP, QMS)
  • Experience with supplier quality and auditing processes
  • Skilled in process improvement and root cause problem-solving methodologies
  • Excellent communication skills with the ability to work collaboratively across departments
  • Proactive, solution-oriented, and able to prioritize multiple tasks in a dynamic environment
  • Fluent in English
  • Dutch proficiency preferred
Job Responsibility
Job Responsibility
  • Ensure food safety and quality compliance for products distributed in EMEA, aligned with ADM policies, regulatory requirements, and customer standards
  • Collaborate closely with factory Quality Managers and Technical Support teams globally (EU, USA, India, Serbia) to optimize quality across the supply chain
  • Provide proactive support and consultation to management on quality issues, regulatory compliance, and food safety improvements
  • Conduct and coordinate internal and external audits
  • host auditors from customers, certification bodies, and governmental agencies
  • Train internal teams on food safety, GMP, and quality principles to ensure compliance awareness
  • Maintain and update quality documentation, including product specifications and Certificates of Analysis (CoA)
  • Manage returned goods workflows, including review, disposition, and corrective actions
  • Support supplier and co-packer qualification, maintaining approval of documentation and performance records
  • Manage product certifications such as Kosher, Halal, and Non-GMO
Read More
Arrow Right
New

Supply Chain Quality Specialist

Randstad Inhouse Services, specialty pharma, is seeking a Quality Supply Chain S...
Location
Location
Italy , Rome
Salary
Salary:
40000.00 - 50000.00 EUR / Year
https://www.randstad.com Logo
Randstad
Expiration Date
July 11, 2026
Flip Icon
Requirements
Requirements
  • Education in Science or Quality topics
  • At least 1 year experience in Quality Operations related activities
  • Quality and technical experience to manage expectations
  • Makes sound and effective quality decisions under pressure
  • Diplomatic in communication with internal and external customers
  • Strong negotiation and effective communication skills
  • Self-motivated individual who is comfortable with working independently
  • Able to lead and work effectively in cross-functional team & collaborate
  • Computer literate
  • English language communication verbal and written
Job Responsibility
Job Responsibility
  • Establish and maintain an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations
  • Deviation Management (in conjunction with the PGS Quality Operations): Investigates, together with appropriate local functions, deviations from Supply Chain Quality requirements that occur within the responsibility of the country organization and agrees and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc
  • Product Complaint handling: Manages the intake of complaints from the local market, assigns class and criticality to the product complaint and forwards them to the appropriate investigating PGS /Contractor Site via the global complaints management system (CITI). Tracks complaint responses Develops and issues responses to complainants in a timely manner
  • Product Quality System: Ensures timely implementation of all applicable Product Quality SOPs (issued by SCESQ) within the PCO. Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs. Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions. Conducts internal assessments to assess compliance with product quality systems & processes, and to identify improvement opportunities. Assess new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required
  • Local Product Disposition: Where required, performs local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country. Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center. Tracks the implementation of the identified actions within agreed timeframes
  • Fulltime
Read More
Arrow Right
New

Specialist, IT Design

Supports the product lifecycle from product definition to product release, worki...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
June 10, 2026
Flip Icon
Requirements
Requirements
  • Agile Methodology
  • Product Testing
  • Usability Testing
  • Requirements Management
  • Data Analysis
  • Wrapper (Data Mining)
  • Continuous Quality Improvement (CQI)
Job Responsibility
Job Responsibility
  • Supports the product lifecycle from product definition to product release, working closely with user teams to meet their requirements
  • Supports the execution and release of products to customers, participating in post-release debugging and assisting with project closeout activities
  • Assists with collection of feature requirements from customers, and translation of those to a definition of non-complex product deliverables
  • Assists with collection of requirements documents for each release
  • Create queries and reports to support business requests that can be used for benchmarking
  • Assists with modelling business processes, learning to adapt application configurations to improve the effectiveness of business operations
  • Assists with check-ins with development teams to ensure deliverables meet business requirements
  • Fulltime
Read More
Arrow Right

Product Development Specialist for Pix - AVP

The Product Development Specialist is a seasoned professional role. Applies in-d...
Location
Location
Brazil , São Paulo
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5-8 years of experience
  • Intellectual curiosity, analytical, and conceptual thinker
  • Proactively seeks and develops new opportunities
  • Detail oriented
  • Ability to build networks and relationships internally and externally
  • Familiarity with product development methodologies
  • Direct experience in end-to-end project delivery, preferably in product development, and knowledge of various analytical tools including Qlikview, Tableau, Access
  • Comfortable with performing data investigations that require a high degree of accuracy with tight timescales
  • Ability to create business analysis, troubleshoot data quality issues, and conduct exploratory and descriptive analysis of business datasets
  • Ability to structure and break down problems, develop solutions, and to drive to results
Job Responsibility
Job Responsibility
  • Responsible for activities related to the development of new products and/or features and functionality of products including developing business cases, requirements definition (BRDs), product enhancements innovation, feature and functionality definition based on market and industry research and trends and client needs
  • Executes on the end-to-end product development lifecycle and will also scope product releases, agreeing to and tracking business priorities, incorporating regulatory and compliance requirements and investment tracking
  • Identifies, gathers, and organizes client insights, internal innovation ideas, marketplace analyses and trends to drive to new concepts
  • Creates a product vision aligned to business priorities and corresponding road-map to delivery
  • Follows market, industry and client trends to own field and adapts them for application Citi's products and solutions platforms
  • Conceptualizes, plans, prioritizes, coordinates design and delivery of products or features to product release, and serves as product ambassador within user community
  • Ensures product delivery is provided in a consistent, professional and high quality level planned and coordinated with unit Manager
  • Works in close co-ordination with Sales, Technology, Business Managers and senior stakeholders to fulfill the delivery objectives
  • Manages and implements a wide variety of products and solutions
  • Identifies solutions ranging across data analytics, reporting, CRM, Trade Workflows and trade processing
  • Fulltime
Read More
Arrow Right

Master Press Tool Tec Support Specialist

Manually sets up and adjusts machine tools and or loading instructions for compu...
Location
Location
United States , Spartanburg
Salary
Salary:
Not provided
bmw.de Logo
BMW
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • AA/AS degree in a technical discipline
  • OR The equivalent of 2 years of experience in a manufacturing environment (automotive preferred)
  • OR Completion of Tech Scholar program
  • 3+ years of related experience in manufacturing processes and/or manufacturing engineering
  • Licenses and Certifications: SC (or other) Department of Labor registered journeyman license as "Tool and Die", "Toolmaker", "Mold maker", "Press Tooling", "Tryout Tooling"
  • 5+ years of MS Office skills (Word, Excel, PowerPoint, Outlook, SharePoint, Access)
  • 5+ years of professional communication skills (written, verbal and presentation)
  • 3+ years of knowledge of manufacturing processes pertaining to assigned parts and applicable systems
  • 3+ years of long and short-term project management skills
  • 3+ years of ability to use and apply statistical problem-solving methods to aid with process analysis
Job Responsibility
Job Responsibility
  • Manually sets up and adjusts machine tools and or loading instructions for computer numeric control (CNC) systems
  • Provides support and skilled direction for Tool room machine operation- i.e. ( Lathes / milling machines etc.)
  • Performs High skill level of welding for press tool die surfaces to A class standards
  • Maintains Working dies to achieve form specifications on A class surfaces
  • Assesses and Interprets Cad designs and replicate into the die surface and dimensional characteristics
  • Supports design reviews to achieve dimensional accuracy and surface repeatability
  • Ensures mature die A class performance into series production
  • Provides Maintenance of A class surface performance to achieve nitriding stages
  • Understands yield stress and tensile strength for making rework decisions on the press tools
  • Understanding material flows relating to material surface oil levels and surface roughness
What we offer
What we offer
  • Medical, Dental, Prescription and Vision coverage
  • Paid time off
  • 401(k) plan with company matching contribution
  • Retirement Income Account
  • Life insurance
  • BMW Associates Assistance Program
  • Medical Flexible Spending Account (FSA)
  • Company vehicle program
  • Fulltime
Read More
Arrow Right