QC Supervisor

Job Description

Job Title: QC Supervisor

Location: Swindon

Position Summary:

This role requires you to operate within a matrix management system to deliver key responsibilities! You will be accountable for the management of a team who provide support to the business with regards to microbiology testing for batch releases in following areas :

• Sterility testing
• Endotoxin testing
• Water testing (Microbiology and Chemical)
• Raw material testing.
• Section critical metrics -QC deviations/CAPAs/Change Controls, batch releases
• Method transfer activities and Qualification of Microbiology testing methods
• Advanced technical support & scientific understanding

Section Responsibilities:

• Line manage a team of 8/9 Microbiologist in Product Integrity section.
• Managing department critical metrics ensuring they are completed on time.
• Carryout one to ones with individuals, performance reviews and setting goals.
• Coordinates with different business units for timely completion of actions meeting business, clients and customer demand.
• Writing & execution of protocols and reports (URS/DQ/IQ/OQ/PQ), organisation of qualification work.
• Ensuring department audit ready all the time to support with client’s, corporate and regulatory body inspections.  
• To lead, plan, coordinate and/or implement timely completion of all tasks ensuring state of control and compliance
• Maintain and control a visual management system showing section status of all key critical metrics.
• Lead and/or support investigations impacting analytical testing.
• Provide technical support and advice to QC Microbiology testing teams and act as first point of escalation in troubleshooting
• Collaborate and coordinate initiatives with other QC Microbiology Section Heads and team for improved compliance, efficiency, HSE, working conditions etc.
• Ensure all trend report for water, bioburdens are completed on time.
• Ensure own work and that of the team aligns with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, analytical methods, Protocols, Guidance’s, etc.
• Ensure own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken. Develop cross functional trained team.
• Identify and drive Practical Process Improvement initiatives (PPI) focussing improved efficiency and compliance.
• Undertake/support Self-inspections, GEMBA walks and Huddle meetings as relevant.
• Undertake ad-hoc activities that may be required by the business
• Support and encourage a “Quality Culture” and company 4i values throughout QC.

Technical responsibilities:

• Act as Subject Matter Expert with regulators / clients (i.e. key part of audits and inspections). Ensure QC Microbiology processes are up to date with the regulatory and pharmacopeia updates.

Leadership Responsibilities:

• Management: Manage team and projects ensuring deliverables and expectations are clearly understood. Activities organized to achieve agreed targets and measures of performance.
• Coaching: Helping team in achieving breakthroughs and develop further in their career.
• Team building: Value relationships, understand team dynamics and actively work to build strong team and healthy relationship with other sections.
• Decision making: Be able to make decisions with the information available, problem solving and take initiative to continuously improve process.
• Integrity: Maintain integrity and be able to promote positive environment.
• Communication – Be able to communicate clearly and confidently with the team and higher management.
• Intensity: Demonstrate passion and expertise to drive improved outcomes.
• Effective team leadership in line with GMP/GDP requirements and 4i (Integrity, Involvement, intensity and innovation) values, policies and procedures.

EH&S:

• Understand emergency procedures and align with safe systems of work.
• Ensure compliance with environment, health and safety rules, signage and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications:

• Degree in Microbiology or Biological sciences or strongly related scientific field.
• Substantial experience 5-10 years’ working in a pharmaceutical QC function, preferably within a sterile site.
• Substantial technical experience and ‘hands-on’ knowledge working with calibration, qualification of analytical systems and processes such as balances, Incubators, Endotoxin systems, Microbiology test methods, understanding of microorganisms isolated, utilities and water systems.
• 2+ years’ experience in team leadership (coordination or activities, absence management, conducting appraisals, problem resolution, motivation, coaching/mentoring etc…)
• Extensive experience of equipment and microbiology techniques, good understanding of cGMP/GDP/GLP, pharmacopeia compendial methods and regulatory requirements.
• Good understanding of aseptic processes and techniques.
• Extensive understanding of Data Integrity principles and practical implementation within laboratories.
• Communication skills – verbal and written. Able to deliver presentations, facilitate meetings and trainings, and create reports.
• Good collaboration and conflict resolution skills.
• Good technical writing skills.
• Wants to learn and has a natural curiosity to understand systems and processes.
• Ability to work in a fast-paced environment essential.

What’s in it for you:

• Excellent career progression opportunities with a large and growing global employer.
• Competitive salary & annual incentive bonus.
• Flexible benefits package which includes: 25 days annual leave, plus public holidays; holiday purchase scheme; discounted private health insurance & dental insurance; employer matched pension contributions up to 8%; discounted gym memberships & more.

About us:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.