QC Supervisor

Orion Mining Inc; Dublin; On-site; EUR 43,000 - 50,000; Full time

Job summary

Orion Group Life Sciences is recruiting a QC Supervisor for a multinational biopharmaceutical client in Sligo on a 6-month contract. You will lead a QC cell, ensure testing meets specifications, coach analysts, and drive efficiency and compliance in the lab.

Extensive analytical skills and data integrity focus are required. You will oversee documentation, methods transfer, and regulatory adherence while maintaining quality across raw materials, in-process, and finished products.

Qualifications

• Minimum 4 years analytical experience in the pharmaceutical industry.
• Expert in HPLC, GC, LCMS, GCMS and titration techniques.
• Strong knowledge of regulatory requirements and data integrity.

Responsibilities

• Ensure Lab documentation and computerized systems comply with data integrity policies.
• Ensure timely completion of all laboratory analyses assigned.
• Coach analysts to ensure right first time performance and improve efficiency.
• Maintain 6S excellence across the laboratory.

Skills

HPLC

GC

LCMS

GCMS

Titration

Analytical methods

Regulatory knowledge

QC equipment

Product transfer experience

Education

3rd level qualification in a relevant Science discipline

Job description

Orion Group Life Sciences are currently recruiting a QC Supervisor on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 6-Month contract with potential to extend.

• €31.56 - €36.49 per hour, Benefits: null
• Ireland, County Sligo, Sligo
• Contract

Job Summary

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met. Ensure that all raw materials, in-process, finished product, stability and contract testing and is carried out per schedule and records are maintained to appropriate requirements. Ensure that technical and systems excellence is maintained in the laboratory by ensuring own skills are maintained, by coaching and training analysts to ensure right first-time behaviour and by implementing improved working practices in terms of efficiency, compliance and Right First Time. This position will take full responsibility for an assigned segment of the QC operation for example, Raw Materials & Drug Product Analysis or In-process & API.

Responsibilities

• Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
• Understand Regulations and business processes required to maintain Laboratory Data Integrity.
• Ensuring timely completion of all laboratory analysis assigned.
• Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
• Improving the overall efficiency and velocity within the assigned team.
• Identifying and implementing improvements in analytical practices such as poke yokes.
• Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
• Identifying weaknesses in laboratory performance and working with the laboratory manager to rectify.
• Resolving analytical OOS issues as they arise in a timely manner both through practical work and through Soltraqs.
• Acting as designee for the Laboratory Manager as assigned.
• Ensuring 6S excellence is maintained across the Laboratory.
• Instilling a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory team
• Ensuring that all laboratory test equipment is utilised and maintained correctly.
• Executing and / or supporting projects as assigned by the laboratory manager.
• Maintaining up-to-date, complete and precise records of all tests performed.
• Acting as the primary point of contact for any analytical issues which arise.
• Developing expertise and understanding of current and future analytical techniques.
• Developing and changing of in-house laboratory procedures as appropriate.
• Carrying out verification of testing records as necessary.
• Positively contribute to departmental programs such as CI, BEx and RFT.
• Supports the transfer of new products.
• Completes project work.
• Adheres to and supports all EHS & E standards, procedures and policies.

Supervision Received

• Operates in an environment which is essentially self-managed but with supervision through the Laboratory Manager.
• Analytical Chemist will liaise with the QC coordinator and QC technical trainer to meet department testing timelines.

Supervision Provided

• Provides supervision to 2-12 Direct reports.
• Is responsible for setting annual goals, completing reviews, growth plans and performance management of the team.

Qualifications

• 3rd level qualification in a relevant Science discipline.

Job/Technical Skills

• Minimum 4 years analytical experience in the pharmaceutical industry.
• Proven track record in an analytical role. Must be expert in HPLC, GC,LCMS, GCMS, Automatic titration, Identification techniques.
• Strong knowledge on regulatory requirements.
• Proficient in using analytical equipment in the QC lab.
• Involvement in product transfers / method transfer experience preferred

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