About this role
## Career Category
Quality
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Job Description
Job Summary: QC CAS - Sr Associate
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of Commercial, Stability, Utilities, raw materials and Validation.
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of Milestones associated with specific projects or activities within team
- Strives to complete activities right first time
Extended hours and weekend work flexibility may be necessary as required.
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Specific Job Duties:
- Plan and perform analyses with great efficiency and accuracy.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives and projects that may be departmental or organizational in scope.
- Review protocols and perform assay validation and equipment qualification/ verifications when required.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- May contribute to regulatory filings.
- May conduct lab investigations as necessary.
- Evaluate lab practices for compliance on a continuous basis.
- Approve lab results.
- May interact with outside resources.
- LIMS data coordination of commercial and import testing on site where applicable
- May represent the department/organization on various teams.
- May train others.
Primary Knowledge, Skills, Competencies and Relevant Experience
Knowledge:
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure & continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Skills:
- Communication skills (verbal and written) at all levels
- Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
- Presentation skills
- Escalate issues professionally and on a timely basis
- Decision Making skills
- Teamwork and Coaching others
- Negotiation and Influence skills
- Investigation skills
- Problem solving skills. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
- Ensures compliance within regulatory environment
- Develops solutions to technical problems of moderate complexity
- Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
- Interprets generally defined practices and methods
- Able to use statistical analysis tools to perform data trending and evaluation
- Project Management and organizational skills, including ability to follow assignments through to completion
Competencies:
- Demonstrated ability to work independently and deliver right first time results
- Works under minimal direction Work is guided by objectives of the department or assignment
- Follows procedures
- Refers to technical standards, principles, theories and precedents as needed
- May set project timeframes and priorities based on project objectives and ongoing assignments
- Recognizes and escalates problems
- Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
Relevant experience:
- Bachelor’s degree in a Science related field is required.
- 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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Salary Range
52,756.95 EUR - 71,377.05 EUR