QC Analyst - Astrea

Biotage; Ballasalla; On-site; GBP 32,000 - 42,000; Full time

Job summary

Biotage is seeking a QC Analyst to join our Quality Control team. You will perform laboratory testing of raw materials, intermediates and finished products in a GMP-regulated environment, supporting TT/R&D and ensuring compliance with quality systems.

You will contribute to investigations, documentations, and drive continuous improvement within the QC department while mentoring colleagues as needed.

Qualifications

• At least 1 year of laboratory experience in pharma, biotech or fine chemicals.
• Knowledge of GMP principles, Quality Management Systems and laboratory compliance.
• Understanding of pharmacopoeias, ICH guidelines and industry standards.

Responsibilities

• Perform QC testing of raw materials, intermediates, in-process samples and finished products per approved procedures.
• Conduct stability studies and environmental monitoring testing.
• Support manufacturing and shipping schedules with timely testing results.
• Maintain GMP-compliant laboratory records and documentation.

Skills

GMP principles

Quality Management Systems

pharmacopoeias & ICH guidelines

Analytical techniques

Troubleshooting

Attention to detail

Team collaboration

Communication

Tools

HPLC

GC

AKTA systems

TLC

UV-Visible Spectroscopy

Titrations

FlowCam

Bioburden Testing

Endotoxin Testing

Environmental Monitoring

Job description

Join Our Team as a QC Analyst

We are seeking a motivated and detail-oriented QC Analyst to join our Quality Control team. Reporting directly to the QC Manager, you will play a vital role in supporting manufacturing operations through the testing of raw materials, intermediates and finished products, as well as conducting stability and environmental monitoring studies.

This is an excellent opportunity for an individual with laboratory experience within the pharmaceutical, biotechnology or fine chemical industries who is looking to develop their career within a quality-focused and highly regulated environment.

About the Role

As a QC Analyst, you will be responsible for performing laboratory testing activities that ensure products meet the required quality standards. You will also provide analytical support across the business, including support to Technology Transfer (TT) and Research & Development (R&D) teams.

Working within a GMP-regulated environment, you will contribute to the smooth day-to-day operation of the laboratory while maintaining compliance with quality systems, regulatory requirements and company procedures.

Key Responsibilities

• Perform Quality Control testing of raw materials, intermediates, in-process samples and finished products in accordance with approved procedures.

• Conduct testing associated with stability studies and environmental monitoring programmes.

• Support manufacturing and customer shipping schedules through timely completion of testing activities.

• Perform environmental monitoring of cleanrooms and purified water systems.

• Maintain accurate and compliant laboratory records in line with GMP and Quality Management System requirements.

• Support routine laboratory activities including equipment maintenance, calibration, reagent preparation, housekeeping and document archiving.

• Assist with purchasing laboratory consumables and maintaining laboratory inventory.

• Participate in investigations relating to deviations, out-of-specification results, change controls and corrective actions.

• Support the QC Manager with documentation review and laboratory administration activities.

• Contribute to continuous improvement initiatives and quality enhancements within the department.

• Train, support and mentor colleagues on QC techniques and procedures where required.

• Work collaboratively with cross-functional teams and external laboratory partners.

About You

To be successful in this role, you will have:

Essential Skills & Experience

• At least 1 year's laboratory experience within the pharmaceutical, biotechnology or fine chemical industry.

• Good understanding of GMP principles, Quality Management Systems and laboratory compliance requirements.

• Knowledge of pharmacopoeias, ICH guidelines and industry standards.

• Experience with a variety of analytical techniques including:

  • HPLC

  • GC

  • AKTA systems

  • TLC

  • UV-Visible Spectroscopy

  • Titrations

  • FlowCam

  • Bioburden Testing

  • Endotoxin Testing

  • Environmental Monitoring (contact plates, viable and non-viable monitoring, luminometer testing)

• Strong technical troubleshooting and problem-solving skills.

• Excellent attention to detail with a methodical and organised approach.

• Strong computer literacy, analytical and numerical skills.

• Ability to work independently and as part of a team in a fast-paced environment.

Personal Attributes

• Strong verbal and written communication skills.

• Ability to write clear and concise scientific and technical reports.

• Positive, proactive and collaborative approach to work.

• Willingness to train, coach and support colleagues.

• Ability to build effective working relationships across departments and with external suppliers.

• Flexible approach to work, including supporting overtime or weekend working when required to meet business needs.

Working Environment

• Approximately 80% laboratory based and 20% office based.

• Collaborative and supportive team environment.

• Opportunity to work across multiple areas of quality control, manufacturing support and product development.

Compliance & Quality

The successful candidate will be expected to:

• Adhere to all Health & Safety policies, procedures and regulatory requirements.

• Comply with GMP standards and Quality Management System requirements.

• Support continuous quality improvement initiatives across the organisation.

• Maintain awareness of the impact of laboratory activities on product quality and patient safety.

Why Join Us?

• Opportunity to work in a dynamic and growing organisation.

• Exposure to a wide range of analytical techniques and technologies.

• Ongoing training and professional development opportunities.

• Collaborative team culture focused on quality, innovation and continuous improvement.