Stephanie McLaughlin

I am currently QA Team Leader within Operational QA Department and my role consists of:

• Prioritising tasks according to urgency and importance, optimising workload allocation among team members.
• Assume line management responsibilities for QA Officers and Document Reviewers within the QA Team, including performance appraisals.
• To lead the QA Team with other department Team Leaders in the day to day activities associated with direct manufacturing activities and reporting daily outputs to Quality Management Team.
• To act as quality lead for projects assigned by Head of QA; including supporting client calls, meetings, and review and approval of client associated documentation and QMS.
• Assuming responsibility of batch release for media simulations, non-clinical and clinical batches. This involves reviewing batch folders and all associated documentation; QC Testing results, EM packs, BMR's, Drug product and excipient packs.
• Participate and lead client audits on site.
• Performing training of QA officers and document reviewers to achieve competency as per training plans designed by QA Team Leader.
• QMS Management - Competent in review and closure of non-conformances, corrective and preventative actions, change controls, effectiveness checks. All Environmental monitoring QMS; operator gowning excursions, environmental monitoring excursions.

After a year, I was promoted to Senior QA Officer within the Operational QA Department, based on a shift pattern and acted as senior officer for my team (shift).

My role consisted of all the responsibilities listed as QA Officer and also:

• Review and approval of Validation protocols for equipment and clean room assets.
• Responsible for review and release of clinical clean rooms as per procedures.
• Ensuring day to day activities and tasks covered by shift members, and ensure effective handover communicated with other QA team on other shift pattern.

I spent over 1 year as a QA Officer within the Operational QA Department at Symbiosis, based in Stirling. My role consisted of:

• Developing, improving and maintaining SOP's to ensure compliance with EU/FDA for GMP for the manufacture and testing of pharmaceuticals.
• Performed batch compilation and batch release duties, these include clinical and non-clinical batches. Working towards batch release turn around time targets, to aim to provide best customer service for client.
• Investigated and report Quality issues, escalation to management where required.
• Responsible for issuing and reviewing batch manufacturing records (BMR's).
• QMS Management and closure of records. These records include - Non-conformances, Corrective and Preventative actions.
• Quality oversight of Clinical shipment activities.
• Participate in internal and external client audits

Spent 3 years working within the Virology Department Labs within Thermo Fisher at Inchinnan site, Renfrew. My role consisted of:

• Cell culture maintenance of mammalian cell lines
• Virus screening of bovine serum samples sent from clients using various different procedure and assays
• Cytological staining
• Immunofluorescence
• Viral Titrations
• Only operator responsible for overseeing all operations and testing for the Mycoplasma laboratory.
• Reviewing and updating SOP's
• Raising any deviations in quality management system and overseeing investigation if required.

Worked with multiple departments and developed strong networking skills. This included other laboratories for sample receipt for testing and also Supply chain for shipping requests needed for samples.

Spent 3 years working within the Virology department at SGS Vitrology site based in Clydebank. My role mostly involved:

• Cell tissue culture maintenance of Mammalian cell lines
• Cell seeding
• Preparation of cell culture medium
• Blood preparation, including haemadsorption testing
• Inoculation of positive virus controls
• Titrations
• Inoculation of client test items for assays
• Responsible for being main operator to oversee inoculation and maintenance of RCA assays

Strong communication skills as had to liaise with study directors and managers, on the progress of assays.