Senior QC Scientist

WHO ARE THEY:
Very exciting opportunity to join a unique manufacturing company, who are currently seeking a Senior QC Scientist to join their team on a permanent basis.
  

  
Position Objective:

• To prioritise, sample, test and release raw materials, intermediates, and finished products to strict timescales, to support the business requirements.
• To review the compliance of QC test methods and associated equipment required in support of product release.
• Deputising for the QC Manager when required.

Duties & Responsibilities
Analytical QC Testing:

• Sampling and analytical testing of raw materials, intermediates, and finished products in accordance with approved procedures and current pharmacopoeias.
• Ensuring that procedures are carried out carefully and accurately to eliminate errors.
• Complete laboratory investigations in support of ‘Out of Specification’ results in a timely manner.
• Stability testing of products for new formulations and ongoing stability trials, using physical (e.g., pH) and instrumental (e.g., HPLC, UV) techniques, as appropriate.

Documentation:

• Complete quality actions (i.e., CAPA, Change Control, Audit) to agreed completion dates.
• To contribute to the preparation of Quality reports, including analytical reports (for raw materials and finished products) and Certificates of Analysis (CoA) (for finished products).
• Writing/reviewing Standard Operating Procedures (SOPs).
• Review of GMP documentation and data (Test QR’s, SOP’s, protocols, reports etc).

Laboratory Management:

• To support activities to source and qualify equipment required in support of QC testing to comply with current European Pharmacopoeia and ICH requirements.
• Calibrating analytical equipment, as and when required.

General:

• Working with all members of staff to maintain and develop the positive progressive culture within the company.
• Observing and complying with Good Manufacturing Practice (GMP).
• Observing and complying with company Health and Safety Policies.
• Observing and complying with company Standard Operating Procedures (SOPs).
• Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Qualifications & Experience:

• Educated to degree level in an appropriate scientific discipline with experience in a biopharmaceutical or closely related industry.
• Experience in an analytical laboratory environment together with knowledge of regulatory requirements.
• Computer literate.
• Previous experience working in GMP laboratory.
• Previous experience managing product stability/trend/control chart datasets.
• Previous experience executing ELISA assays.

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