Quality Operations Laboratory Project Specialist

Quality Operations Laboratory Project Specialist

Job Purpose:

To ensure all relevant QC documentation associated with the purchasing, introduction qualification and decommissioning of laboratory equipment and projects are complete to a high standard within the required time frames to facilitate business continuity for the QC Laboratories.

Job Responsibilities:

·      Own multiple project schedules from initiation to closure, liaise with System Owners and attend all relevant project and equipment related meetings to give input on project status.

·      Drive projects to completion by working collaboratively with all parties to implement project deliverables to project plans.

·      Support the execution of QC instrument equipment throughout the initial validation lifecycle by liaising with Vendors, Calibration, Engineering, EHS, QA and QC partners

·      Responsible for setting up new equipment in LIMS and EAMS.

·      Own and participate in QO Project forums

·      Assist with the coordination of the management of space within the QC labs with respect to equipment.

·      Assist with the decommissioning process for equipment to ensure that equipment is decommissioned in a timely manner to maximize the space available to the labs for the introduction of new equipment.

·      Work with Engineering to ensure that the Fixed Asset Register (FAR) is accurate and up to date, to include performing annual asset counts.

·      Drive process efficiencies tracking and reporting on improvements including cost, productivity and waste/rework as it relates to the management of projects and introduction of laboratory equipment.

·      Work with Engineering to ensure ready to use equipment tracker is accurate.

·      Trouble shooting common Quality Control instrumentation.

·      Write and generate PIRFs and Customer Requirement Documents (CRD’s) as necessary to allow Engineering to begin the purchasing process associated with each project or piece of equipment.

·      Complete Regulatory Assessment forms to aid with the categorization of qualification of new equipment.

·      Write the User Requirement Specification (URS) document for each piece of equipment or project required.

·      Write and raise change controls in the QTS system as required. (in project phase = QO Projs)

·      Present change controls at the change control forum for endorsement. 

·      Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements.

·      Participate in new initiatives such as the 5S, Standard Work, Data Integrity and IMEX programs as they arise.

·      Participate in and drive the continuous improvement of all aspects of the group.

·      Ensure compliance with cGMP, corporate standards / Pfizer Quality System (PQS), site policies / procedures, and regulatory requirements.

·      Technical writing assignments including SOPs, trend reports, risk assessments, laboratory investigations, and change controls.

Education/Experience

·      To be successful in this role the following are prerequisites to application:

·      You will be delivery focused and can build rapport with key stakeholders both internal and external.

·      Hold a B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent experience in a regulated industry.

·      Preferable 2-4 years’ experience in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment.

·      Proven documentation skills with ability to generate text and write a document in a clear and unambiguous way, ensuring all relevant detail is covered.

·      Experience working with a documentation system e.g. PDOCs and an investigation/change control system e.g. QTS.

·      Demonstrated ability to successfully collaborate, influence and lead in a matrix organisation

·      Proven track record in working with Quality related projects

·      Excellent communication and interpersonal skills

·      Proven record in demonstrating agility and working in a fast-paced environment

·      Experience of involvement in technical issue resolution, in a multidisciplinary environment

·      Experience with trouble shooting Quality Control instrumentation.

·      Good working knowledge of IT systems and their interactions with laboratory instrumentation would be considered an advantage but not essential