Quality Assurance Specialist

Summary of the QA Specialist role

As the QA Specialist you will report directly to the Senior QA Specialist and be based at our site in Cramlington, Northumberland.

The main purpose of your role will be to perform batch sentencing activities on a named set of products and all quality assurance activities (reviews/approvals/audits etc) relating to those products and specific plant/business areas. You will maintain quality systems covering specific areas of expertise, working in accordance with GMP and regulatory standards.

Your responsibilities

• As a SAP user the job holder will be required to carry out assigned SAP transactions in an accurate and timely manner.
• Sentence all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These cover production and analytical review, deviation and change assessment.
• Responsible for all QA approvals of PRSs, changes (process, analytical and engineering procedures) which relate to specific products to ensure they are carried out in accordance with relevant product registrations.
• Perform QA assessment of all 'Decision Paths', non-conformances and deviations (including out of calibration).
• Review all cGMP cleanouts and ensure manufacture is not commenced prior to completion of a satisfactory cleanout.
• Ensure that specific product set and specific plant/business areas are cGMP compliant through audit, review and monitoring. Identify relevant corrective actions and ensure they are closed out through QATs.
• Maintain QA systems covering change control
• Approval of master PRSs and procedures
• Handle complaints, audit observations and customer notifications and coordinate annual reviews.
• Responsible for coordinating validation activities
• Complying with all environmental, health and safety requirements.
• Embodying our company values, which are: be reliable, be caring, be transparent and be willing.

Requirements for the role

• Degree or equivalent in a scientific discipline.
• Experience within Active Pharmaceutical Ingredient or Pharmaceutical Industries, in quality assurance.
• Comprehensive knowledge of all GMP requirements/guidelines applicable to API manufacture
• API quality assurance, laboratory practices and production.
• Auditing experience internal/external.
• Excellent skills in communication and the writing of SOPs and reports

How you will be rewarded

We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research, development and clinical manufacturing services.

We are a fast growing, dynamic business with facilities in the UK, US and Europe, where we employ talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

How to apply

If you have the necessary skills and experience to join our team, please apply online. For any queries or should you require any reasonable adjustments to support your application please contact us.

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

We reserve the right to close this vacancy early if we receive sufficient applications for the role. Therefore, if you are interested, please submit your application as early as possible.

Job Type: Full-time

Benefits:

• Additional leave
• Canteen
• Company pension
• Cycle to work scheme
• Employee discount
• Health & wellbeing programme
• On-site parking
• Private medical insurance
• Referral programme

Ability to commute/relocate:

• Cramlington NE23 7QG: reliably commute or plan to relocate before starting work (required)

Work authorisation:

• United Kingdom (required)

Work Location: In person