Lead Quality Assurance Specialist

3 weeks ago

Berwick, Northumberland, United Kingdom Sterling Pharma Solutions Full time

Overview of the Lead Quality Assurance Specialist Position

In the capacity of Lead Quality Assurance Specialist, you will collaborate closely with the Senior Operational Quality Manager. This role is integral to our Quality team, focusing on ensuring the highest standards of quality for our products.

Your primary responsibilities will include conducting thorough batch assessments and overseeing all quality assurance processes, including reviews, approvals, and audits related to designated products and specific operational areas. You will be responsible for upholding quality systems that adhere to current Good Manufacturing Practices (cGMP) and regulatory requirements.

About Sterling Pharma Solutions

Sterling Pharma Solutions is a rapidly expanding global Contract Development and Manufacturing Organisation (CDMO) with over five decades of expertise in the development and production of Active Pharmaceutical Ingredients (APIs). We pride ourselves on being a reliable partner to some of the most innovative biotech firms and leading pharmaceutical companies, recognized for our proficiency in complex and hazardous chemistry.

Our dynamic workforce comprises over 1300 dedicated professionals across the UK, US, and Europe, all committed to assisting our clients in bringing new medications to market and enhancing patient outcomes. We support our clients throughout the entire product lifecycle, from pre-clinical development to large-scale commercial manufacturing, fostering a culture of scientific excellence and unparalleled service.

Your Key Responsibilities

  • Conducting timely sentencing of all controlled intermediates and finished products in accordance with established procedures, including production and analytical reviews, as well as deviation and change assessments.
  • Overseeing quality assurance approvals for Process Record Sheets (PRS's) and changes related to specific products, ensuring compliance with product registrations and customer notification protocols.
  • Performing quality assessments of all 'Decision Paths', non-conformances, and deviations, including those involving calibration issues.
  • Reviewing cGMP cleanouts to ensure that manufacturing does not commence until satisfactory cleanout is confirmed.
  • Approving essential documents, including master Process Record Sheets (PRS's), monographs, and operational procedures.
  • Utilizing the Master Control electronic quality management system for document and deviation approvals, as well as SAP for batch management and release.
  • Adhering to all environmental, health, and safety regulations.
  • Embodying our core values: Be Transparent, Be Willing, Be Reliable, and Be Caring.

Qualifications for the Role

  • Proven experience in quality compliance management.
  • Preferred educational background includes a degree or equivalent in a scientific discipline.
  • Strong problem-solving abilities, effective communication skills, and the capacity to work collaboratively within a multidisciplinary team.
  • In-depth knowledge of cGMP, MHRA, and other regulatory standards is essential.
  • Alignment with our core values: Be Transparent, Be Willing, Be Reliable, and Be Caring.

Why Join Sterling?

Our unique collaborative and empowering culture distinguishes us as a leading employer. This culture is founded on our four core values: Be Transparent, Be Reliable, Be Willing, and Be Caring. We actively promote health, well-being, and work-life balance through various initiatives, support charitable causes, and encourage community involvement. Our global social committees also organize events to foster team building and recognize our employees' hard work.

At Sterling, we celebrate diversity and mutual respect, recognizing that our varied backgrounds and perspectives enhance our workplace and drive innovation and collaboration.

We offer a competitive compensation and benefits package, including bonuses, pension schemes, private healthcare, and opportunities for professional development.

Be caring. Be transparent. Be willing. Be reliable.

  • Lead Quality Assurance Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Sterling Pharma Solutions Full time

    Overview of the Lead Quality Assurance Specialist PositionIn the role of Lead Quality Assurance Specialist, you will collaborate closely with the Senior Operational Quality Manager. This position is primarily site-based, operating on a standard weekday schedule.As a vital member of our Quality team, your key responsibility will be to execute batch approval...

  • Culinary Support Specialist

    2 weeks ago

    Berwick, Northumberland, United Kingdom BEN-Motor and Allied Trades Benevolent Fund Full time

    Job Title: Culinary Support SpecialistAre you interested in contributing to an organization that positively impacts the lives of individuals and communities?Our Company Benefits for Culinary Support Specialist:Joining our team offers you:31 days of annual leave (including enhanced bank holidays) proratedLife insurance coverageComplimentary parking...

  • HSEQ Lead Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Osbit Full time

    Présentation d'Osbit :Nous sommes Osbit. Nous concevons et construisons des systèmes d'ingénierie de pointe pour permettre le développement à grande échelle de l'énergie éolienne offshore.Nous fournissons des équipements d'ingénierie dans de nombreux domaines technologiques, facilitant des opérations offshore clés telles que l'installation de...

  • Workplace Experience Specialist

    2 weeks ago

    Berwick, Northumberland, United Kingdom ISS Full time

    About ISS ISS is a global leader in workplace and facility management, dedicated to creating exceptional experiences for our clients and their employees. We understand that the workplace environment plays a vital role in productivity, well-being, and overall success. Role Overview As a Workplace Experience Specialist, you will be an integral part of our...

  • Maintenance Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Wellburn Care Homes Limited Full time

    About UsAt Wellburn Care Homes Limited, we pride ourselves on being a family-owned establishment that values individuality. Our approach to hiring is centered around personality and cultural fit, ensuring that every team member feels like part of our family.Role OverviewThe Maintenance Specialist plays a crucial role in ensuring the functionality and...

  • Care Support Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Turning Point Full time

    Job Overview Are you seeking a fulfilling role where you can truly impact the lives of others? Do you envision yourself assisting adults in enhancing their independent living abilities and leading fulfilling, active lives? If you answered YES to these questions, we invite you to explore this opportunity. Role Summary As a Care Support Specialist,...

  • Care Support Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Turning Point Full time

    Position Overview Are you interested in a fulfilling role that positively impacts individuals' lives and aids them in reaching their aspirations? Do you envision yourself assisting adults in enhancing their autonomy and leading a purposeful and active lifestyle? If you find yourself nodding in agreement, we encourage you to explore this opportunity...

  • Care Assistant

    3 days ago

    Berwick, Northumberland, United Kingdom BEN-Motor and Allied Trades Benevolent Fund Full time

    About UsBEN-Motor and Allied Trades Benevolent Fund is a leading provider of person-centred care services, dedicated to delivering high-quality care to residents in a supportive and inclusive environment.Job Title: Care AssistantWe are seeking a compassionate and skilled Care Assistant to join our team at Birch Hill care Centre. As a Care Assistant, you will...

  • Maintenance Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Wellburn Care Homes Limited Full time

    About UsAt Wellburn Care Homes Limited, we pride ourselves on being a family-oriented organization that values individuality. Our approach to hiring is centered around personality and the ability to integrate into our close-knit team. We believe that every person brings something unique to the table, and we cherish that diversity.Position OverviewThe...

  • Maintenance Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Wellburn Care Homes Limited Full time

    About UsAt Wellburn Care Homes Limited, we pride ourselves on being a family-oriented organization that values individuality. Our approach to hiring focuses on the unique qualities of each person, ensuring that we find candidates who not only possess the necessary skills but also fit seamlessly into our team culture.Role OverviewThe Maintenance Specialist...

  • Maintenance Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Wellburn Care Homes Limited Full time

    About UsAt Wellburn Care Homes Limited, we pride ourselves on being a family-oriented organization that values individuality. Our approach to hiring focuses on personality and cultural fit as much as it does on qualifications. We believe that every team member contributes uniquely to our mission.Position OverviewThe Maintenance Specialist plays a crucial...

  • Spa Treatment Specialist

    1 day ago

    Berwick, Northumberland, United Kingdom Haven Full time

    Join Our Team as a Spa Treatment Specialist Become a valued member of Haven's professional team as a Spa Treatment Specialist. You will provide a variety of beauty services while ensuring an outstanding experience for our clients. Enhance the Spa's visibility to attract more guestsAdminister treatments with precision and careUphold the Spa and facilities to...

  • Spa Treatment Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Haven Full time

    Join Our Team as a Spa Treatment Specialist Become a valued member of Haven's professional team as a Spa Treatment Specialist. You will provide a variety of beauty services while ensuring an outstanding experience for our clients. Enhance the Spa's visibility to attract more guestsAdminister treatments with precision and careUphold the Spa and facilities to...

  • Administrative Support Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    Position OverviewNorthumbria Healthcare NHS Foundation Trust is seeking to appoint a dedicated and detail-oriented Administrative Support Specialist to join our Physiotherapy team.Key ResponsibilitiesProvide comprehensive administrative and clerical assistance to the physiotherapy department, collaborating closely with senior administrative staff and...

  • Administrative Support Specialist

    3 weeks ago

    Berwick, Northumberland, United Kingdom Northumbria Healthcare NHS Foundation Trust Full time

    Position Overview Northumbria Healthcare NHS Foundation Trust is seeking to appoint a dedicated and organized Administrative Support Specialist to join our Physiotherapy team. Key Responsibilities Provide comprehensive administrative and clerical assistance to the physiotherapy department, collaborating closely with senior administrative staff and Clinical...

  • Plant Harvest Specialist

    1 day ago

    Berwick, Northumberland, United Kingdom Frontier Agriculture Limited Full time

    Exciting Opportunity at Frontier Agriculture LimitedWe are seeking a skilled Harvest Specialist to join our team at Frontier Agriculture Limited, a leading agricultural business in the UK. As a key member of our harvest team, you will play a crucial role in ensuring the success of our operations.Key Responsibilities:Coordinate and deliver a high standard of...

  • Plant Harvest Specialist

    1 week ago

    Berwick, Northumberland, United Kingdom Frontier Agriculture Limited Full time

    Exciting Opportunity at Frontier Agriculture LimitedWe are seeking a skilled Harvest Specialist to join our team at Frontier Agriculture Limited, a leading agricultural business in the UK. As a key member of our harvest team, you will play a crucial role in ensuring the success of our operations.Key Responsibilities:Coordinate and deliver a high standard of...

  • Wastewater Production Specialist

    2 days ago

    Berwick, Northumberland, United Kingdom Randstad UK Holding Full time

    About the RoleWe are seeking a highly skilled Wastewater Production Specialist to join our team at Randstad UK Holding. As a key member of our operations team, you will play a vital role in ensuring the efficient and effective operation of our wastewater treatment facilities.Key ResponsibilitiesOperate and control wastewater treatment works and pumping...

  • Nurse Specialist

    5 days ago

    Berwick, Northumberland, United Kingdom Akari Full time

    Job Summary:Akari Care is seeking a dedicated and compassionate Registered Nurse to provide exceptional care to our residents. As a key member of our team, you will play a vital role in delivering high-quality clinical and medical assistance while fostering a supportive and inclusive environment.Key Responsibilities:Deliver personalized care to residents,...

  • Nurse Specialist

    5 days ago

    Berwick, Northumberland, United Kingdom Akari Full time

    Job Summary:Akari Care is seeking a dedicated and compassionate Registered Nurse to provide exceptional care to our residents. As a key member of our team, you will play a vital role in delivering high-quality clinical and medical assistance while fostering a supportive and inclusive environment.Key Responsibilities:Deliver personalized care to residents,...