Senior QC Investigations Analyst

Kindeva Drug Delivery; United Kingdom; On-site; GBP 30,000 - 45,000; Full time

Job summary

Kindeva Drug Delivery is seeking a Senior QC Investigations Analyst to lead laboratory investigations and ensure compliance with quality standards. The ideal candidate will have a degree in a relevant field and experience in a QC lab, contributing to continuous improvement initiatives and regulatory compliance. This role offers an attractive compensation package and career development opportunities in a dynamic environment.

Benefits

Attractive compensation package

Company pension scheme (up to 10% employer contribution)

25 days holiday plus bank holidays

Company sick pay

Employee Assistance Program (24/7 support)

Life assurance of four times salary

Wellness programmes

Employee recognition program

Free on-site parking

Discount and cashback at retailers

Qualifications

• 3+ years of experience in a QC laboratory environment with a focus on investigations.
• Proven ability to conduct detailed scientific investigations.
• Strong understanding of GMP regulations.

Responsibilities

• Lead and manage laboratory investigations.
• Ensure compliance with Good Manufacturing Practices.
• Support continuous improvement in QC operations.

Skills

Attention to Detail

Problem Solving

Time Management

Education

Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Tools

HPLC

GC

UV-Vis

LIMS

Microsoft Word

Microsoft Excel

Job description

Bishop Meadow Rd, Loughborough LE12, UK Req #1910

Our Work Matters:

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Role Overview:

We are seeking a highly skilled and detail-oriented Senior QC Investigations Analyst to join our Quality Control (QC) team. In this critical role, you will lead and manage a variety of laboratory investigations, ensuring compliance with Good Manufacturing Practice (GMP) and company quality standards.

Apply your analytical expertise to identify root causes, drive effective corrective and preventive actions (CAPAs), and support continuous improvement in QC operations.

Working across cross-functional teams to support calibration activities and ensuring Good Documentation Practices, you will represent the department and include managing the external customers and regulators.

Key Responsibilities include, but are not limited to:

• Work to appropriate laboratory systems, standards and procedures, (e.g., data recording, labelling, investigation and calibration procedures).
• Complete analytical documentation including the input of results onto the LIMS system.
• Awareness of current regulatory standards as applicable to laboratory functions.
• Champion GMP / GLP standards and principles within the laboratory area.
• Provide support / technical expertise to resolve problems with analytical testing.
• Complete preliminary investigations.
• Complete full-scale investigations with minimal support.
• Review and issue GMP documentation where full training has been received.
• Develop an understanding of the tests carried out and their impact on the products / materials worked on.
• Oversee the maintenance and calibration of laboratory equipment.
• Support continuous improvement activities within own group.
• Participate as a team member for Group CI projects as appropriate.
• Communicate with auditors and general employee expectations during an audit.
• Create basic project plans to detail activities and proposed timelines for laboratory / function-based activities.

Skills & Experience:

• Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 3+ years of experience in a QC laboratory environment, with a focus on investigations is preferable.
• Proven ability to conduct detailed scientific investigations.
• Strong understanding of GMP regulations, to follow the 10 rules of GMP.
• Previous experience working with GLP, Specifications and Test Methods
• Experience with analytical techniques such as HPLC, GC, UV-Vis, etc., is an advantage.
• Knowledge and application of current safety regulations (e.g., CoSHH) as applicable to laboratory functions.
• Computer literate, familiar with Microsoft Word and Excel.

Key Capabilities:

• Good organisational, interpersonal, and time management skills.
• Strong attention to detail and problem-solving mindset.
• Enthusiastic, flexible, conscientious and proactive in approach.
• Take a positive approach to own training and development.
• Good decision-making and problem-solving skills.
• Strong verbal and numerical aptitude skills.
• Strong team player with the ability to work independently.

What we Offer:

• Attractive compensation package.
• Company pension scheme (up to 10% employer contribution).
• 25 days holiday per year (plus bank holidays) plus service days after 5 years.
• Company sick pay.
• Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
• Life assurance of four times life cover salary.
• Wellness programmes.
• Employee recognition program.
• Free on-site parking.
• Discount and cashback at many retailers.
• Cycle to work scheme.

Additional Information:

Location: Derby Road, Loughborough

All applicants must be eligible to work in the UK.

We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.