Position Summary
This role is responsible for ensuring the laboratory operations in accordance to ISO 17025 and cGMP requirements.
He/She will serve as analytical lead in a variety of projects which includes but is not limited to method validation, method transfer, customized testing activities.
In addition, this individual is responsible for directing the day‐to‐day project activity through interaction with technical personnel while gathering, analyzing and interpreting scientific data.
He/She must ensure accurate and precise results are being achieved and properly reported.
Duties & Responsibilities
Provides strong, independent technical leadership to technical personnel
Leads, designs and performs method development (i.e. bioassay and mycoplasma) and validation of new test procedures for incoming projects
Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests
Evaluates analytical results to form interpretations of data and renders scientific opinions for client‐driven projects
Serves as subject matter expert (SME) in area of specialization, established standards for regulatory compliance
Serves as technical liaison with Customers with regards to technical services and performs Customer site visits where required
Prepares documents including methods, procedures, standard operating procedures (SOP), study protocols, summary reports
Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements
Provides problem‐solving skills for test procedures and investigations within laboratory unit
Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in a timely manner
Monitors all proficiency‐based testing and ensures compliance
Participates in internal Quality Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities
Participates in quarterly management review
Drives process, quality and safety improvement initiatives within the department
Provides coaching and mentoring to Technical personnel
Supports the Laboratory Manager in all relevant functions
General Requirements
Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.
Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.
Performs all other related duties as assigned.
Qualifications
Bachelor of Science or any related field; MSc. preferred but not essential
Minimum 2-6 years of relevant QC microbiological experience working in an ISO 17025 / GMP laboratory environment
Experience in method validation and development, method transfer, qualification activities in regulated laboratory
Good knowledge of ISO 17025, cGMP and other regulatory guidelines
Good understanding/working knowledge of Project Management and Measurement Uncertainty (MU)
Good technical understanding and judgement
Good interpersonal and communication skills across cultures
Team player with ability to work in cross‐functional teams as well as independently depending on requirement of task on hand
Please submit resumes to
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