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Quality Control Analyst
3 months ago
Quality Control Analyst – 9 months contract – Liverpool - £18.50 per hour Umbrella - Biotechnology companyOverview:Supports the QC Compliance and Improvement Manager in providing compliance support across QC activities.
Participate in site improvement project teams, drive quality decisions, and provide advice and technical support where required. You will deal with internal and external contacts.
Internal contacts – Data inputs from Supply Chain, Operational Teams, and Project and AS&T teams, which must be reviewed and interpreted to maximise laboratory resources in line with site objectives.
Works closely with the QC Managers, QC labs, and SME's. External contacts- Global Quality Systems and Compliance for changes in Health Authority expectations. Daily interaction with VWR who manage site consumables and reagents via in-plant personnel.Responsibilities:
Work closely with the labs to lead Deviations, CAPA's, and Change Controls through to on-time completion.
Participate in lab improvement projects.
To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment are applied in all activities, in accordance with current regulations and procedures.
Ensure QC compliance with Company PoliciesSupport QC labs with respect to sample delivery from across the Liverpool sites to the labs in a timely manner.
Keep oversight of and facilitate on time completion of DR's, CAPA's, Change Controls and SOP UpdatesMonthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review.
To collate data relating to site and organisational changes that will impact the efficient running of the laboratories.Manage the completion of DR's, CAPA's, Change Controls and SOP updates working closely with the QC labs.
Attendance at and presentation at DRB.CAPEX project submissions and management.
Invalid reporting.
Maintenance of QC metrics. PPS problem-solving.
Must haves:
cGMP background in the Pharmaceutical industryExperience of Quality Control / Microbiological testing techniques and industry practicesKnowledge and understanding of Lean Lab principles.
Proven time management skillsProven communication skills both written and verbal.
Academically trained to a minimum of degree standard in a relevant scientific discipline