Target Salary Range:$77,900 - $103,800 per year (salary to be determined by education, experience, knowledge, skills and abilities of applicant, internal equity, and alignment with market data)
RESPONSIBILITIESLeadership/ 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 updated 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
Your ApplicationTo ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at www.evonik.com/en/careers.html.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:Robin Rose
Company is
Evonik Canada Inc.
