COMPANY OVERVIEW:
Sampled enables clients to advance human health by leveraging active biological samples through preservation, immortalization and utilization in comprehensive multiomics research within the only leading-edge Global Integrated Analytical Biorepository.
Sampled is committed to building a sustainable, inclusive and diverse culture where team members enjoy equal opportunities in a safe, supportive and empowering environment. Sampled believes that as an organisation we have a duty to be actively engaged in supporting not just the clients and industries we serve but the communities where we live and work.
This is a fabulous opportunity for an accomplished and team focused Manager to join our Glasgow management team. If you are looking for a role where you are pivotal to business success, relied upon for operational excellence and strategic thinking, this could be the position for you.
POSITION SUMMARY:
The Storage Operations Manager will be responsible for the effective and safe operation of the Storage Suites and off-site ambient Warehousing, ensuring all activities meet client requirements and are in accordance with Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP) and Quality Control standards. This position reports to the Sr. Director Global Technical Services.
RESPONSIBILITIES:
• Lead and develop departmental teams and individuals to ensure the following are achieved efficiently, accurately and in a safe manner:
o Sample Receipt activities: Receiving, moving, labeling and storing incoming goods to GMP standards. This includes handling biological samples at various temperatures.
o Check and inspect goods received, ensuring they are of accurate and acceptable quantity, type and quality prior to storing.
o Assemble, pack and label commodities to GMP standards prior to dispatch to clients.
o Ensure all inventory processes are completed on the required day.
o Work with courier companies to coordinate dispatch and delivery as required.
• Represent the Company in client visits and client / regulatory audits.
• Manage and complete financial invoicing through appropriate system
• Act quickly to resolve any operational issues and escalate as appropriate.
• Plan for equipment validation and servicing, in liaison with Technical Services team and Facilities Manager
• Prepare and review quality documents including standard forms, study protocols, SOPs, change controls and deviations.
• Complete actions to maintain the Quality Management System, ISO 9001:2015 accredited:
o Maintain folders and spreadsheets in the quality system within Egnyte, study folders and client folders.
o Perform periodic reviews of all relevant documentation in the quality system and ensure that reviews are conducted in a timely manner.
o Assist in external / internal audits, where required.
o Liaise with the commercial team, where required.
• Strive to continuously improve processes / workflows to achieve optimum effectiveness and efficiency, and consistently high standards for clients.
• Take personal responsibility to deliver storage services to a consistently high standard, making suggestions for improvement, and encouraging the team to do the same.
• Follow Standard Operating Procedures and adhere to all safety and company policies.
• Be an effective leader providing support, training, guidance and mentorship to team members. Ensure the team remains up to date on training, including but not limited to SOP training, competency training, regulatory training and safety training.
• Work across departments as required, providing advice and guidance on Storage services and capabilities as required.
• Champion of the Sampled Values: Strive to delight our clients, Move innovation forward, Accelerate your business, Rise together as a team, Transcend what is possible.
• Perform related responsibilities as needed.
POSITION REQUIREMENTS:
• Ideally a Bachelor’s degree in science or relevant industry experience
• 5+ years of relevant experience managing the storage of samples including biological samples within a regulatory environment.
• Previous managerial experience. Experienced in hiring and developing staff.
• Experience working in a customer orientated environment where services are provided business to business. Prior experience in Biotech or Pharma industry would be advantageous.
• Proven deep knowledge in following Good Manufacturing Practice (GMP)
• Strong understanding of ISO 9001: 2015, ISO 20387 and MHRA requirements for pharma stability storage and wholesale distribution authorization (WDA)
• Excellent root cause analysis/CAPA, problem solving, and analytical skills.
• Good IT skills: email, spreadsheets and data entry.
• High level of accuracy and attention to detail.
• Good communication skills, both verbal and written. Able to communicate effectively with clients, regulators, visitors, suppliers and colleagues.
• Demonstrates consistently good communication and interpersonal skills with employees and management. Engages the team and other stakeholders, able to navigate through change.
• Good interpersonal skills, Acts professionally at all times. Easily builds rapport with others. .
• Results driven: Demonstrates the desire to achieve the best possible results. A self-starter, able to work with limited supervision.
• Strong planning, prioritization and organization skills.
• A desire to learn and progress within the business.
