QA Manufacturing Compliance Specialist

Job title:

QA Manufacturing Compliance Specialist

Company

Hero Recruitment

Job description

We are currently seeking a dedicated and detail-oriented Quality Assurance professional with strong experience in sterile manufacturing and aseptic practices to join our team. This role offers a unique opportunity to play a key part in maintaining high-quality standards across the production of biologic drug products in a highly regulated GMP environment.If you have a solid background in quality operations, a passion for compliance, and thrive in aseptic settings, we’d love to hear from you!KEY RESPONSIBILITIESEnsure that all drug products, both commercial and investigational, meet the required quality standards prior to release.Verify that products and aseptic process simulations meet internal requirements, regulatory expectations, and end-user needs.Provide quality and compliance oversight to Operations, ensuring adherence to all relevant site procedures and policies.Maintain a strong presence on the manufacturing floor during aseptic operations, including oversight of aseptic interventions.Lead or assist in investigations stemming from process deviations or non-compliance.Review and audit completed batch manufacturing records and logs as necessary.Conduct quality reviews of operational documents, including SOPs, JSTMs, and risk assessments.Perform line clearance activities prior to production runs.Execute raw material checks and maintain product status as required.Support the Stability Program through sample pulls, weekly checks, and protocol preparation when needed.Maintain finished product status and oversee labeling activities.Administer quality-related logs (e.g., QA Hold, Sample Requests).Lead daily walkthroughs of manufacturing areas to support compliance and continuous improvement.Champion process simplification and continuous improvement within Operations to sustain compliance.Provide additional quality support as required.KEY REQUIREMENTSBachelor’s degree in a science, quality, or engineering discipline.Ideally, prior experience in a quality-focused role.Minimum of 2 years’ experience in a GMP-regulated quality or operations role. Experience in biologics manufacturing is highly desirable.Strong background in aseptic processing within a quality or manufacturing environment is highly preferred.In-depth knowledge of regulatory compliance standards is essential.CORE SKILLSExceptional attention to detail and ability to maintain accuracy under pressure.Strong analytical and problem-solving skills with adaptability to changing priorities.Innovative mindset with the ability to introduce and implement practical solutions.Results-oriented, consistently meeting performance targets and metrics.Committed to delivering high-quality outcomes and maintaining a Right First Time approach.Strong verbal and written communication skills.Excellent interpersonal skills and a collaborative approach.Demonstrates integrity, professionalism, and a strong work ethic.EHS RESPONSIBILITYComplies with all EHS policies and procedures.Prioritises safety—personally and for others—by following guidelines and reporting hazards.Actively participates in the EHS program, including incident reporting and improvement suggestions.Completes all required EHS training and medical surveillance activities. * Wears appropriate PPE at all times.Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters
For further information on this role please contact Róisín Vaughan on 086 440 3742 / consult@hero.ieCheck out all our open jobs on our HERO Recruitment website –Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Expected salary

Location

Sligo

Job date

Thu, 01 May 2025 07:41:18 GMT

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