QC Sample Management Analyst

We at Orion Group are currently recruiting a QC Sample Management Analyst on behalf of one of our Multinational Pharmaceutical Clients in Liverpool to work on a 12-month contract.

To support the site stability programme by effectively co-ordinating the QC sample management of receipt and delivery of 3rd party samples and sample retains in compliance with ICH, WHO, the company quality guidelines and SOP's and other regulatory requirements.

RESPONSIBILITIES

• To track the receipt of third party samples against the shipping schedule and routine/stability sample requests escalating any delays in receipt of samples to the stability management team.
• Sample third party routine samples and distribute to the laboratories in a timely manner to prevent delays to batch release. Receive stability samples, reserve samples and retain samples from third party suppliers and store/distribute following site procedures.
• Supervises the use of chemical tests and various kinds of measuring instruments in accordance with approved methods and standard operating procedures (SOPs)
• To co-ordinate sample shipments from Liverpool site to third party reciprocates following site procedures, ensuring efficient delivery. Submission of sample requests, collection of requested samples from formulation department and management of sample storage in support of site stability studies. To sample stability material at the respective time point using both aseptic and non-aseptic techniques, label the samples and distribute to the QC and Microbiology laboratories, adhering to the stability time point sampling windows.
• Manage the storage, annual inspection and disposal of the final product retain samples on behalf of the site Qualified Person(s)
• To own and support sample management and QC logistics based deviations, and support continuous improvement activities relating to job role/function.
• Responsible for receipting QC samples from 3rd parties and subsequent delivery to the QC labs which will be measured through by the lead times for the batch release.
• Responsible for co-ordinating sample shipments from Liverpool site to 3rd parties and stability sample management between internal departments.
• Responsible for performing aseptic sampling manipulations
• Responsible for efficient sample management practices within QC
• Liaise with manufacturing, QA, Supply Chain and the QC labs for the receipt/distribution of samples
• Identifies best practice and ensures that it is appropriately shared.

CAPABILITIES

• Fluency in English
• cGMP background in the Pharmaceutical industry
• Experience of Quality Control testing techniques and industry practices
• Proven time management skills for planning and schedule of work
• Proven Communication skills both written and verbal.
• Graduate level in a related discipline

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.