Senior QC Associate
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.
Preferred:
* Bachelor's degree in a Science related field is required.
* 2+ 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.
* 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.
* 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.
* 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.
* 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.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on