Quality Specialist, Product Release Job at Baxter (Mississauga)

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

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

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

Center Quality Specialist

Essential Job Responsibilities and Duties and Qualifications

Location

United States , Fort Pierce

Salary:

Not provided

Assessfirst

Expiration Date

Until further notice

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

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

Quality Assurance Packaging Specialist

This position within the QA department provides Quality oversight, support and k...

Location

Ireland , Cork

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

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

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

Qa specialist

Responsible for executing the food safety and quality strategy for the Specialty...

Location

Netherlands , Amsterdam

Salary:

Not provided

ADM

Expiration Date

Until further notice

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

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

QA senior specialist

Lead quality initiatives and build a thriving QA function within a dynamic inter...

Location

Japan , Tokyo

Salary:

6000000.00 - 10000000.00 JPY / Year

Randstad

Expiration Date

May 13, 2026

Requirements

3+ years of experience in Quality Assurance within a regulated IVD/MD company
Experience working in an international organization
Experience supporting audits with Competent Authorities/Notified Bodies
Excellent written and spoken English
Strong understanding of Japanese regulations for Molecular Diagnostics (IVDs) and Devices
Proven ability to lead projects and drive continuous improvement initiatives
Experience with eQMS and eDMS/eTMS systems
Strong collaboration and communication skills
Problem-solving and analytical skills
Experience working with 3PLs or warehouse management is a plus

Job Responsibility

Lead quality initiatives and build a thriving QA function within a dynamic international team
Lead local project implementations and contribute to larger global projects
Maintain and improve the company's QMS, implementing local solutions as needed
Manage quality systems such as document control, utilizing global eQMS and eDMS/eTMS systems
Support internal, external (regulatory/Notified Body), and supplier audits
Collaborate with the Global CAPA team to resolve customer issues related to molecular diagnostic (MDx) products
Partner with the Warehouse/3PL team to ensure efficient operations, including product release and re-labeling
Handle quality-related inquiries

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

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