34 Quality Control jobs in Leekbrook
Quality Control Reviewer
Posted 5 days ago
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Job Description
Role: Quality Control Reviewer
Business Unit: Bioscript Regulatory Writing
Location: Macclesfield / London (Hybrid or remote - UK)
About Us
Established in 2005, Bioscript Group is formed from multiple, specialist businesses to support our global pharmaceutical clients; we draw on their multidisciplinary expertise to help navigate critical decisions at key points in the product lifecycle.
Our scientific and strategic expertise helps our clients make better decisions. We provide medical communication services, market access consulting and regulatory writing support with deep domain expertise to effectively navigate complex disease areas.
The Opportunity
The role of the Quality Control Reviewer is to conduct quality control (QC) and other supportive activities to support delivery of accurate, compliant and submission-ready documents prepared by writers in Bioscript Regulatory Writing (including internal and external writers), or by clients.
Key Responsibilities
- Perform QC review and manage QC projects in accordance with agreed upon timelines.
- Verify accuracy of document content using source documents including, but not limited to, clinical regulatory documents (e.g. protocols, clinical study reports, CIOMS reports, clinical summaries/overviews), statistical analysis plans and data tables, figures, and listings.
- Verify internal consistency within a document and across related documents.
- Verify uniformity and compliance of documents with internal or client standards (e.g. document templates, style guide, publishing requirements).
- Record QC findings and identify appropriate corrections to address findings.
- Collaborate with document authors and other team members (as needed) to resolve QC findings.
- Proactively share knowledge and experience to support transfer of knowledge across the team.
- Take responsibility for ensuring optimum use of own time. Flag capacity or bottlenecks to the QC Manager so that resource can be allocated most efficiently. Efficiently manage competing projects, proactively flagging potential issues to the QC Manager.
- Support the Project Management team by monitoring the progress of all assigned projects against the agreed QC schedule and QC budget specification.
- Support the regulatory writing team (eg, supporting other QC Reviewers, editorial support for writers (eg, populating tables, drafting narratives etc).
- Understand QC and publishing processes and strategy, client procedures, and best practice for projects.
- Proofread, edit, compile, and publish regulatory documents according to BRW or client conventions and applicable regulatory and industry guidance.
- Ensure adherence to agreed client/Bioscript standard operating procedures.
About You
- Previous experience working as a QC Reviewer / Regulatory Writer within an agency or pharmaceutical setting
- Previous experience of document publishing preferred
- Attention to detail to ensure accuracy and quality in all deliverables
- Ability to take initiative and manage multiple tasks independently
- Strong communication skills
Our people are at the heart of our business
We are focused not just on delivering the exceptional for our clients, but for our teams too. We understand everyone is different and believe in treating everyone as an individual with opportunities to develop your skills and career around our disciplines.
Our benefits include:
- Salary which aligns with your experience and skillset
- 25 days holiday + bank holidays + winter shutdown + holiday purchase scheme
- Enhanced sick and compassionate leave
- Enhanced maternity, paternity & adoption leave
- Birthday charity donation to a charity of your choice
- Bonus Day off to be spent giving back to the community
- Life Insurance and Critical Illness cover
- Private Medical (Vitality for UK based colleagues)
- Health cash plan or wellbeing allowance
- International Employee Assistance Program
We are committed to creating an inclusive and diverse workplace. We encourage applications from all individuals who meet the minimum requirements of the role. If you require any reasonable adjustments during the application or interview process, please contact us via or by calling .
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Senior Pharmaceutical Quality Control Analyst
Posted 1 day ago
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Job Description
Key Responsibilities:
- Perform analytical testing of raw materials, intermediates, and finished pharmaceutical products.
- Operate and maintain laboratory equipment such as HPLC, GC, UV-Vis spectrophotometers, and dissolution apparatus.
- Conduct method validation and transfer activities.
- Interpret analytical data and generate accurate reports.
- Investigate out-of-specification (OOS) results and deviations.
- Ensure compliance with GMP, FDA, and other regulatory standards.
- Participate in internal and external audits.
- Contribute to the development and optimization of analytical methods.
- Maintain laboratory records and documentation in accordance with regulatory requirements.
- Collaborate with R&D, Production, and QA teams.
- Bachelor's or Master's degree in Chemistry, Pharmacy, or a related life science discipline.
- Minimum of 5 years of experience in pharmaceutical quality control.
- Hands-on experience with analytical techniques like HPLC, GC, and spectroscopy.
- In-depth knowledge of GMP and regulatory requirements in the pharmaceutical industry.
- Strong understanding of analytical method validation.
- Excellent laboratory skills and meticulous attention to detail.
- Proficiency in data analysis and report writing.
- Good communication and teamwork skills.
- Experience with laboratory information management systems (LIMS) is a plus.
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Apprentice Laboratory Technician - Quality Control
Posted 2 days ago
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Job Description
As an apprentice, you will be involved in a range of activities, from preparing samples and conducting routine tests to recording results accurately and assisting with data analysis. You will learn to operate and maintain laboratory equipment, ensure adherence to strict safety and quality standards, and contribute to the overall efficiency of the quality control department. The ideal candidate will be detail-oriented, possess good numeracy skills, and have a genuine interest in science and laboratory work. A proactive approach to learning and a commitment to precision are essential.
Key Responsibilities:
- Prepare chemical samples for analysis according to standard operating procedures.
- Perform routine laboratory tests and analyses using appropriate equipment.
- Record experimental data accurately and maintain detailed laboratory notebooks.
- Assist in the calibration and maintenance of laboratory instruments.
- Learn and apply various analytical techniques.
- Ensure compliance with health, safety, and environmental regulations within the laboratory.
- Support the quality control team in ensuring product consistency and integrity.
- Participate in training sessions and contribute to continuous improvement initiatives.
- Manage laboratory consumables and maintain stock levels.
- Minimum of 4 GCSEs (or equivalent) at grade C/4 or above, including science subjects, Maths, and English.
- A keen interest in chemistry, science, and laboratory work.
- Strong attention to detail and accuracy.
- Good numeracy and literacy skills.
- Ability to follow instructions precisely and work systematically.
- Willingness to learn and adapt to new techniques.
- Team-oriented attitude with good communication skills.
- Commitment to completing the full apprenticeship program.
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Quality Control Manager - Automotive Components
Posted 2 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with IATF 16949 standards.
- Lead and manage the quality control team, including inspectors and technicians.
- Establish quality control standards and procedures for all manufacturing processes and finished products.
- Conduct internal and external audits to ensure compliance with quality standards and regulations.
- Analyze quality data, identify trends, and implement corrective and preventive actions (CAPA).
- Oversee product inspection, testing, and validation processes.
- Manage non-conformance reporting and resolution processes.
- Collaborate with engineering and production teams to address quality issues and implement improvements.
- Ensure supplier quality through audits and performance monitoring.
- Develop and deliver quality training programs for employees.
- Monitor key quality metrics and report on performance to senior management.
- Drive continuous improvement initiatives to enhance product quality and process efficiency.
- Stay up-to-date with automotive industry quality standards and best practices.
- Bachelor's degree in Engineering, Quality Management, or a related field. Master's degree preferred.
- Minimum of 7 years of experience in quality control or quality assurance, with a significant portion in the automotive industry.
- Proven experience in developing and implementing IATF 16949 compliant QMS.
- Strong knowledge of quality control tools and methodologies (e.g., SPC, FMEA, APQP, PPAP).
- Experience leading and managing a quality team.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong understanding of manufacturing processes, particularly in automotive component production.
- Proficiency in quality management software and data analysis tools.
- Excellent communication, leadership, and interpersonal skills.
- Ability to work effectively and autonomously in a remote environment.
- Auditor certification (e.g., IATF 16949 Lead Auditor) is highly desirable.
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Senior Quality Control Manager - Manufacturing
Posted 7 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain comprehensive quality control policies, procedures, and standards across all manufacturing operations.
- Oversee the inspection and testing of raw materials, in-process components, and finished goods to ensure they meet predefined specifications.
- Lead and mentor a team of Quality Control technicians and inspectors, providing guidance and performance management.
- Manage the calibration and maintenance of all quality control equipment and instrumentation.
- Investigate quality deviations, customer complaints, and non-conformances, implementing corrective and preventive actions (CAPA).
- Conduct internal audits to ensure compliance with quality standards and regulatory requirements.
- Collaborate with production, engineering, and R&D teams to resolve quality issues and implement process improvements.
- Analyse quality data to identify trends, report on key performance indicators (KPIs), and drive continuous improvement initiatives.
- Ensure adherence to relevant industry standards and certifications (e.g., ISO 9001).
- Manage the quality control budget and resource allocation effectively.
- Bachelor's degree in Engineering, Science, or a related field. A Master's degree is a plus.
- Minimum of 7 years of progressive experience in Quality Control or Quality Assurance within a manufacturing environment.
- Proven experience in developing and implementing quality management systems (QMS).
- Strong understanding of statistical process control (SPC), Six Sigma methodologies, and Lean manufacturing principles.
- Excellent leadership, team management, and problem-solving skills.
- Proficiency in using quality control software and data analysis tools.
- Exceptional attention to detail and commitment to accuracy.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with various departments.
- Experience working in a remote leadership capacity is essential.
- Knowledge of relevant industry regulations and standards.
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Senior Quality Control Manager (Remote)
Posted 9 days ago
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Remote Senior Quality Control Inspector
Posted 22 days ago
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Job Description
Key Responsibilities:
- Develop, implement, and manage comprehensive quality control plans for cleaning and sanitation services.
- Conduct virtual inspections of facilities and operations using provided tools and platforms.
- Assess adherence to health, safety, and sanitation regulations and company standards.
- Analyse inspection data, identify trends, and generate detailed reports with actionable recommendations.
- Collaborate with site managers and cleaning staff to address identified issues and implement corrective actions.
- Train and mentor junior quality control personnel on best practices and inspection techniques.
- Maintain accurate and up-to-date documentation of all inspection activities and findings.
- Stay informed about relevant industry standards, best practices, and regulatory changes.
- Utilise specialised software and tools for remote monitoring and reporting.
- Champion a culture of quality and continuous improvement within the organisation.
- Proven experience in quality control, inspection, or a related field within the cleaning or sanitation industry.
- In-depth knowledge of health, safety, and sanitation regulations.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Proficiency in data analysis and report generation.
- Excellent communication and interpersonal skills, with the ability to effectively interact with various stakeholders remotely.
- Experience with remote work technologies and virtual inspection tools is highly desirable.
- Ability to work independently, manage time effectively, and meet deadlines.
- Relevant certifications in quality management or sanitation are a plus.
- Bachelor's degree in a relevant field or equivalent professional experience.
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Senior Pharmaceutical Quality Control Analyst
Posted 24 days ago
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Job Description
Responsibilities:
- Perform analytical testing of raw materials, in-process samples, and finished products using various instrumental and wet chemistry techniques (e.g., HPLC, GC, UV-Vis, Karl Fischer titration).
- Develop, validate, and transfer analytical methods in accordance with regulatory guidelines (ICH, FDA, EMA).
- Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Maintain detailed and accurate laboratory records, ensuring compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
- Operate and maintain laboratory equipment, ensuring proper calibration and performance.
- Review and approve analytical data and reports generated by junior analysts.
- Participate in internal and external audits, providing necessary documentation and explanations.
- Contribute to process improvement initiatives within the Quality Control department.
- Stay updated on regulatory requirements and scientific advancements in pharmaceutical analysis.
- Train and mentor junior QC analysts, fostering a culture of scientific excellence.
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related discipline.
- Minimum of 5 years of experience in pharmaceutical Quality Control or analytical development.
- Extensive hands-on experience with analytical instrumentation, particularly HPLC and GC.
- Strong knowledge of pharmaceutical regulations (GMP, ICH guidelines).
- Proven ability to develop, validate, and transfer analytical methods.
- Excellent understanding of pharmaceutical product development and manufacturing processes.
- Strong investigative and problem-solving skills, particularly in resolving OOS investigations.
- Proficiency in data analysis and interpretation, with strong attention to detail.
- Effective written and verbal communication skills.
- Ability to work collaboratively in a team-oriented environment.
- Experience with LIMS (Laboratory Information Management System) is an advantage.
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Senior Pharmaceutical Quality Control Analyst
Posted 25 days ago
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Job Description
Key Responsibilities:
- Perform a variety of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, and dissolution testing.
- Develop and validate analytical methods according to regulatory guidelines (e.g., ICH).
- Review and interpret test results, ensuring they meet predefined specifications.
- Document all laboratory activities meticulously, maintaining accurate and complete records in accordance with GMP (Good Manufacturing Practices).
- Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Prepare and review quality control documentation, including test methods, specifications, and reports.
- Maintain laboratory equipment, ensuring proper calibration and functionality.
- Stay current with pharmaceutical regulations, pharmacopeial standards (e.g., USP, EP), and industry best practices.
- Participate in internal and external audits as required.
- Mentor and train junior analysts.
- Contribute to continuous improvement initiatives within the quality control department.
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical quality control or analytical development.
- Proficiency in common analytical techniques such as HPLC, GC, KF titration, and spectrophotometry.
- Thorough understanding of GMP, ICH guidelines, and pharmacopeial requirements.
- Experience with method validation and OOS investigations.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent attention to detail and accuracy in record-keeping.
- Proficiency in laboratory information management systems (LIMS) and standard office software.
- Ability to work independently and manage multiple tasks effectively in a remote setting.
- Strong written and verbal communication skills.
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Remote Senior Quality Control Analyst - Pharmaceutical
Posted 3 days ago
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Job Description
Key Responsibilities:
- Perform complex analytical testing on raw materials, intermediates, and finished pharmaceutical products using advanced instrumentation (HPLC, GC, UV-Vis, etc.).
- Develop, validate, and transfer analytical methods according to regulatory guidelines.
- Execute instrument qualification (IQ/OQ/PQ) and calibration programs.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results, identifying root causes and implementing corrective actions.
- Interpret analytical data, prepare comprehensive reports, and review data generated by other analysts.
- Ensure all activities are conducted in compliance with GMP, regulatory requirements, and internal SOPs.
- Contribute to the continuous improvement of QC processes and analytical methodologies.
- Mentor and train junior QC analysts on analytical techniques and laboratory procedures.
- Collaborate with R&D, manufacturing, and regulatory affairs to support product development and lifecycle management.
- Maintain accurate and detailed laboratory records.
- Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 7 years of hands-on experience in pharmaceutical quality control or analytical development.
- Proficiency in operating and maintaining analytical instruments such as HPLC, GC, FT-IR, UV-Vis spectrophotometers.
- Demonstrated experience with method validation, OOS investigations, and regulatory compliance (GMP).
- Knowledge of pharmacopoeias (USP, EP, JP) and relevant ICH guidelines.
- Excellent data interpretation, report writing, and problem-solving skills.
- Strong organizational and time management abilities for remote work.
- Effective written and verbal communication skills.
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