Quality Control Senior Associate

Career Category

Quality

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.

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Contributes to team by ensuring the quality of the tasks/services provided by self

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Contributes to the completion of Milestones associated with specific projects or activities within team

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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

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• Plan and perform analyses with great efficiency and accuracy.
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• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
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• Report, evaluate, back-up/archive, trend and approve analytical data.
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• Troubleshoot, solve problems and communicate with stakeholders.
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• Initiate and/or implement changes in controlled documents.
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• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
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• Review protocols and perform assay validation and equipment qualification/ verifications when required.
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• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
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• May contribute to regulatory filings.
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• May conduct lab investigations as necessary.
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• Evaluate lab practices for compliance on a continuous basis.
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• Approve lab results.
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• May interact with outside resources.
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• LIMS data coordination of commercial and import testing on site where applicable
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• May represent the department/organization on various teams.
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• May train others.

Primary Knowledge, Skills, Competencies and Relevant Experience

Knowledge

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• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure & continuous learning
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• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Skills

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• Communication skills (verbal and written) at all levels
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• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
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• Presentation skills
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• Escalate issues professionally and on a timely basis
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• Decision Making skills
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• Teamwork and Coaching others
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• Negotiation and Influence skills
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• Investigation skills
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• Problem solving skills. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
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• Ensures compliance within regulatory environment
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• Develops solutions to technical problems of moderate complexity
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• Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
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• Interprets generally defined practices and methods
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• Able to use statistical analysis tools to perform data trending and evaluation
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• Project Management and organizational skills, including ability to follow assignments through to completion

Competencies

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• Demonstrated ability to work independently and deliver right first time results
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• Works under minimal direction Work is guided by objectives of the department or assignment
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• Follows procedures
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• Refers to technical standards, principles, theories and precedents as needed
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• May set project timeframes and priorities based on project objectives and ongoing assignments
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• Recognizes and escalates problems
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• Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
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• Auditing documentation and operation process
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• Demonstrated ability to interact with regulatory agencies

Relevant experience

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• Bachelor’s degree in a Science related field is required.
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• 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
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• 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