QC Specialist

Evonik España Y Portugal SA.; Burnaby; On-site; CAD 90,000 - 130,000; Full time

Job summary

Evonik Canada Inc. sucht eine erfahrene QC-Führungskraft zur Koordination von Qualitätskontrollprozessen in CDMO-Projekten. Sie steuern Ressourcen, planen Master-Schedules und berichten an das Site-Team. Ihre Expertise hilft, termingerechte Ergebnisse zu liefern.

Sie verfügen über 5–8 Jahre Erfahrung in Qualitätskontrolle/Projektmanagement, beherrschen Lean/Six Sigma und arbeiten selbstständig in einem regulierten Umfeld mit exzellenten Schreib- und Kommunikationsfähigkeiten.

Qualifications

• BSc. oder MSc. in Chemie, Biochemie, Mikrobiologie, angewandte Wissenschaften oder Äquivalent.
• Ca. 5–8 Jahre Erfahrung in der parenteralen Pharma- oder Biopharma-Industrie.
• Erfahrung im Qualitätscontrolling ist stark bevorzugt, inkl. Projekt- und Ressourcenplanung.
• Bewährte Fähigkeiten in der Anwendung von Programm-Management-Tools (LEAN, Six Sigma).
• Ausgeprägte Time-Management- und Organisationsfähigkeiten in reguliertem Umfeld.

Responsibilities

• Als QC-Vertreter Input für Kundenprojekte liefern.
• An regelmäßigen Meetings teilnehmen; QC-Fortschritte berichten.
• QC-Master-Plan/Pläne erstellen und an Lieferpläne anpassen.
• QC-Team führen, Probenmanagement und Tests gemäß SOPs durchführen.
• Referenzstandards beschaffen, pflegen und ausgabenüberwachen.
• Mit PM zusammenarbeiten, um Projektergebnisse termingerecht zu liefern.

Skills

Quality Control

Project management

Resource planning

LEAN processes

Six Sigma

Technical writing

Communication skills

Time management

Regulatory compliance

Interpersonal skills

Microsoft Word/Excel/PowerPoint/Visio

Education

BSc./MSc. in Chemistry/Biochemistry/Microbiology/Applied sciences or equivalent

Tools

Microsoft Word

Excel

PowerPoint

Visio

Job description

Was wir bieten

Bei Evonik sind Sie Teil eines weltweit aktiven Chemieunternehmens und arbeiten an den Schnittstellen der wichtigsten Technologien und Industrien. Ob gesunde Ernährung, klimaschonende Mobilität oder grüne Energie – unsere Produkte verbessern das Leben der Menschen, heute und morgen.

Nach unserer Überzeugung entsteht Erfolg nicht im Alleingang, sondern durch Ideenvielfalt und Teamarbeit. Ob Naturwissenschaften oder Ingenieurwesen, Berufseinstieg oder mit Berufserfahrung, ob im Geschäft, in der Produktion oder in welchem Bereich wir auch arbeiten – wir motivieren uns gegenseitig, egal wie groß die Herausforderung auch sein mag. Seien Sie dabei, seien Sie „Part of Something Special.“!

Informieren Sie sich gerne über unsere vielfältigen Benefits:

https://www.evonik.com/de/karriere/warum.html

Hier erfahren Sie mehr über Evonik direkt von unseren Mitarbeitern:

https://www.evonik.com/de/news/unser-team.html

RESPONSIBILITIES

Leadership / Functional:

• Proactively collaborate with stakeholders of various functional groups to prioritize the work for QC to meet the business needs to achieve the best-in-class operation for a Contract Development and Manufacturing Organization (CDMO)
• Be able to effectively influence QC team members to optimize the planning, daily and weekly QC schedules, and operational activities
• Identify gaps and define implementation strategies to achieve operational efficiencies and improvements

Operational Excellence & Planning:

• Act as a QC representative to provide operational input for clients' projects
• Attend routine operational and project meetings; provide QC progress updates to Project Management and the site operational team
• Bring strategic / tactical plans into attainable QC actions to achieve on‑time delivery of tasks and projects
• Communicate status of QC activities to external stakeholders and project-related updates to QC Manager
• - Prepare / revise and manage the QC master schedule / plans (including QC resource allocation and planning) to ensure proper alignment with business plan and delivery schedules
• Support the leading of the QC team to ensure all sample management and testing activities are performed efficiently and effectively, in accordance with approved SOPs, GxP requirements and expectations and EHSS requirements. Sample management includes cross‑functional collaboration for RM sampling, arrangement of external testing, utilities and environmental monitoring as well as proactive communication with those external labs regarding testing requirements and timelines for batch disposition.
• Draft drug product specification & sampling plans
• Ensure all stability projects are captured and maintained accurately in the QC system, which includes but is not limited to the following:
• Prepare stability protocols accurately in accordance with the project requirements for internal and external review and approval in a timely manner
• Ensure all stability samples are pulled and scheduled for testing within the defined timeframe
• Support periodic inventory count of all stability samples performed by the assigned QC analyst(s)
• Perform peer review and approval of QC data related to testing of raw material, in‑process, release and stability materials
• Support the team to assure all reference standards are received and managed accurately in accordance with site procedure, includes but is not limited to:
• Coordinate with Project Management to receive the reference standards from Clients
• Coordinate the purchasing of the required reference standards
• Accurately maintain the master list of reference standards; proactively manage the expiry / re‑test dating to assure adequate supply of standards are available for testing as per defined schedule
• Participate in project(s) and temporary assignment(s) as assigned

REQUIREMENTS

• BSc. Or MSc. in Chemistry, Biochemistry, Microbiology, applied sciences or equivalent
• Approximately 5 to 8 years of experience in the parenteral pharmaceutical or biopharmaceutical industry
• Experience working in Quality Control is strongly preferred, with experience in project management, resource planning, and a CDMO environment as assets
• Proficient in real-life application of various program management/ resource planning tools (e.g.,LEAN processes, Six Sigma, etc.) to drive operational excellence/ efficiencies
• Proven time management and organizational skills to work in a fast‑paced, regulated environment and manage multiple projects concurrently.
• Demonstrated ability to think critically within applicable regulations for regulatory compliance and operational excellence
• Excellent technical writing, problem-solving, and communication skills.
• Detail oriented to assure accuracy of data and information.
• Effective and professional interpersonal skills with abilities to collaborate with others across multiple functions.
• Self‑motivated with abilities to work in an undefined environment.
• Flexibility in work hours may be required
• Proficient in computing (e.g.,Microsoft Word, Excel, PowerPoint, Visio, etc.) and performing appropriate data analysis and risk assessment

Ihre Bewerbung

Um eine schnellstmögliche Bearbeitung Ihrer Bewerbung zu gewährleisten und die Umwelt zu schonen, bewerben Sie sich bitte online über unser Karriereportal. Weitere Informationen über Evonik als Arbeitgeber finden Sie unter www.evonik.com/de/karriere.

Ihr Talent Acquisition Manager:

Robin Rose

Evonik Canada Inc.