Bioprocess Associate

Morgan McKinley; Dublin; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Morgan McKinley is seeking a QA Specialist on an 11-month contract with hybrid work in Ireland. The role focuses on data integrity, cGMP compliance, and continued quality improvements across manufacturing records, deviations, CAPAs, and change controls.

The ideal candidate holds a science-related degree and 3–5 years in regulated pharma/biotech environments, with strong analytical, writing, and stakeholder management skills to support product release and quality activities.

Qualifications

• 3–5 years in a regulated pharma/biotech environment.
• Experience with quality systems, deviations, CAPAs, change controls, investigations.
• Knowledge of GMP requirements and quality system standards.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Lab, Supply Chain.

Responsibilities

• Ensure ALCOA data integrity for records and data.
• Complete required cGMP training and ensure compliance with regulations.
• Drive cGMP/GDP compliance in day-to-day activities.
• Escalate potential quality violations and aid in resolution.
• Collaborate with QA leads and QPs to resolve quality queries.
• Support introduction of new products for site release.
• Promote processes and procedures for all quality activities.
• Monitor Quality Management Systems and generate performance reports.
• Review and approve manufacturing batch/material documentation.
• Identify improvement opportunities to enhance compliance and efficiency.

Skills

Quality systems

GMP compliance

Analytical thinking

Communication skills

Stakeholder management

Data integrity

Regulatory interpretation

Microsoft Office

Documentation

Problem solving

Education

Bachelor's degree in Science/Engineering/Quality/Pharmaceutical disciplines

Quality Management Certifications desirable

Tools

Electronic quality management systems

Job description

QA Specialist - 11 Month Contract with potential extension- Hybrid

The position is responsible for activities including those listed below, alongside any other tasks as required by the business.

Core Responsibilities

• Ensure data integrity principles—Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA)—are adhered to for records and data in day-to-day business activities.
• Attend and successfully complete applicable cGMP training.
• Respond to operational and business areas while driving compliance with cGMP and corporate regulations.
• Drive cGMP/GDP compliance in the performance of day-to-day business activities.
• Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products, and aid in their resolution.
• Liaise with Quality/Business Area Specialists, QPs, and QA Leads to resolve quality-related queries where required.
• Provide expertise and quality support for the introduction of new products onto the site in relation to product release where required.
• Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
• Report on and assist with monitoring the Quality Management Systems, generating reports for performance metrics and significant quality events or issues.
• Review and approve all manufacturing batch/material documentation, including electronic batch records, real-time reports, and master data using site systems where required.
• Identify, influence, and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.

Education

• Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
• Relevant industry qualifications or certifications in Quality Management Systems, Compliance, Auditing, or Operational Excellence are desirable.

Experience

• Typically 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
• Demonstrated experience working within Quality Systems and Compliance functions, including management of quality records, deviations, CAPAs, change controls, investigations, complaints, and document management systems.
• Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations.

Skills and Competencies

• Strong understanding of Quality Management Systems and GMP compliance requirements.
• Excellent analytical and problem-solving skills with the ability to evaluate complex quality issues and identify sustainable solutions.
• Strong written and verbal communication skills, including technical writing and report preparation.
• Ability to manage multiple priorities and deliver results within agreed timelines.
• Effective stakeholder management skills with the ability to influence across functions and levels of the organization.
• Strong attention to detail and a commitment to maintaining data integrity and quality standards.
• Ability to interpret regulatory requirements and translate them into practical site procedures and processes.
• Proficiency in Microsoft Office applications and electronic quality management systems.
• Demonstrated capability to drive continuous improvement and support a culture of quality and compliance.

Preferred Experience

• Experience with site Quality Systems governance, metrics, compliance monitoring, and inspection readiness activities.