Job Title:

QC Analyst

Job Summary:

We are seeking a highly skilled QC Analyst to join our team at SRG. As a QC Analyst, you will play a critical role in ensuring the quality of our products and services.

Key Responsibilities:

• Support the Quality Assurance Department in ensuring that all aspects of the manufacture of medicinal products are performed in a controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice.
• Assure that manufactured products are compliant and fit for purpose.
• Perform analysis of samples and support technical investigations/monitoring, using a range of analytical techniques related to the testing of micronised API including Particle Size Analysis (PSA) and HPLC for assay and impurities.
• Prepare and check analytical data accurately according to company, customer, and regulatory requirements.
• Assess the quality and accuracy of analytical results and determine if material meets pre-defined acceptance criteria.
• Undertake analysis as required to support process investigations or as part of process qualification and validation exercises.
• Be responsible for assigned items of Laboratory equipment or 5S standards.
• Be responsible for the safety of self and others within the Laboratory.
• Analyse samples according to pre-defined test methods, specifications, or Pharmacopoeia.
• Ensure analytical records follow ALCOA principles (attributable, legible, contemporaneously recorded, original, and accurate).
• Be responsible for ensuring that Laboratory work areas maintain high standards of housekeeping and meet requirements such as 5S.
• Be responsible for maintenance and calibration of Laboratory equipment as assigned by Laboratory Team Leader.
• Be responsible for ensuring equipment used is calibrated, validated, and fit for use. Deficiencies are resolved promptly in consultation with the responsible person or expert user.
• Analyse samples safely and compliantly, meeting all required standards of EHS legislation and GMP, such as COSHH, Risk Assessments, and DSE.
• Document and communicate Laboratory issues, such as safety, compliance, and analytical issues giving rise to invalid data.
• Ensure sample solutions, standards, and test media are used within expiry dates, or re-evaluated as appropriate.

Requirements:

• Relevant Science Degree (for example Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Forensics) or equivalent, with up to 1- or 2-years practical work experience.
• Experienced in QC testing of micronised API including Particle Size Analysis (PSA) wet and dry technics on MS 2000, MS3000, and Sympatec Helos equipment and HPLC for assay and impurities.
• Proficient in the use of numerous Laboratory instruments, software packages, and other analytical techniques (e.g. Empower 3).
• Proficient in problem-solving and may have expertise in troubleshooting analytical equipment.
• Competent in the application of statistical and mathematical tools and formulae.
• Aware of relevant national/international Pharmaceutical regulatory authorities.
• Competent in the use of corporate IT systems.
• Computer literate and competent in the use of Microsoft packages.
• Effective verbal and written communication skills.
• Enthusiasm to work in a laboratory-based role.