Qualifications

• 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
• 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

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of EU Release, 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.
• Extended hours and weekend work flexibility may be necessary as required.

Responsibilities

• 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.

Qualifications

• 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
• 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.