- Aug 14, 2023
As an Quality Control Equipment Specialist, you'll play an important role in the day-to-day operation of the laboratories.
As an Quality Control Equipment Specialist, you'll play an important role in the day-to-day operation of the laboratories. Working as part of the QC Laboratory Equipment Validation Team you will be responsible for the qualification of new instrumentation, modernization of instrumentation, and facility modification or expansion projects within the QC Laboratories.
The Quality Control Equipment Specialist reports to the Quality Control Associate Director and has responsibility for the implementation, qualification, and maintenance of equipment in the QC laboratories. You will liaise with external equipment vendors and will manage all equipment preventative maintenance schedules. The candidate will maintain all equipment related documentation and must be able to perform their duties with minimum supervision.
- Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle:
- New instrument and equipment validation (URS, IQ, OQ, PQ, Traceability Matrices, Summary Reports
- Periodic review of instrument qualification packages as required
- Routine QC support with respect to instrument issues
- Instrument and equipment validation scheduling
- Administration of Laboratory Computerized Systems.
- Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
- Preparation and review of required validation documentation including protocols and reports.
- Ensure data integrity requirements are included and met as part of the new instrument qualification.
- Establishment of procedures for management and maintenance of the validated system (data archive, project creation, security etc.).
- Generation of area and System Administration SOPs.
- Authoring, review and approval of qualification/validation protocols and reports, status reports, regulatory documents and process descriptions.
- Completion of Security reviews, periodic reviews, compendial reviews and APQR sections as they relate to maintaining the qualified status of the system
- Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required.
- Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.
- Partner closely with customers and stakeholders to understand QC instrument and equipment validation requirements and escalate when necessary.
- Proactive engagement with customers and key stakeholders.
- Maintain the QC laboratories in a state of audit readiness at all times.
- Participate in new initiatives such as the 5S, Standard Work, Data Integrity programs as they arise.
- Participate in and drive the continuous improvement of all aspects of the group.
- Ensure compliance with cGMP, corporate standards, site policies / procedures, and regulatory requirements.
- Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
Qualifications and Skills Required:
- You will be service orientated; delivery focused and can build rapport with key stakeholders both internal and external.
- Relevant Third level Qualification or equivalent (B.Sc. degree in science, engineering, quality, technical or other related life sciences or engineering discipline.
- 5+ years relevant experience in industry, preferably in a pharmaceutical or relevant GMP manufacturing environment.
- A strong knowledge and experience of validation or qualification experience with laboratory instrumentation, validation and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.
- Excellent communication and interpersonal skills.
- Proven experience in updating documentation and reports.
- Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Morgan McKinley are working in partnership with Horizon Therapeutics