Associate Quality Specialist

PSC Biotech Corporation; Tipperary; On-site; EUR 60,000 - 75,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a Contract Associate Quality Specialist to support day-to-day QA activities within the Quality Systems CoE, ensuring robust compliance with global cGMP standards. This role will oversee deviation investigations, CAPA, supplier qualification, and QA support for analytical/microbial labs, including environmental monitoring and validation oversight.

The 11-month contract offers exposure to top pharmaceutical client sites, collaboration across

Qualifications

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline.
• 3+ years of Quality Assurance, Quality Systems, or Laboratory QC/Microbiology experience in a highly regulated GxP pharmaceutical or biopharmaceutical manufacturing environment.
• Experience reviewing analytical/microbiological laboratory investigations (OOS/OOT), laboratory change controls, stability protocols, environmental monitoring data, or sterility assurance parameters.
• Knowledge of method validation, verification, and transfer principles.

Responsibilities

• Deviation Trending & Support: QA oversight for deviation investigations and root-cause analysis.
• CAPA Management: Define and execute effective corrective and preventive actions.
• Customer Complaint Management: Coordinate investigations and draft reports with cross-functional teams.
• Annual Reviews: Prepare product, process, and system reviews for regulatory compliance.
• Analytical & Microbiological QA Support: QA partner for labs, review change controls and validation data.
• Validation, Equipment & GMP Compliance: oversight of IQ/OQ/PQ and regulatory submissions.

Skills

Quality Assurance

CAPA Management

Deviation Investigation

GxP Compliance

Supplier Qualification

Education

Chemistry / Microbiology / Biology

Tools

SAP Master Data

Kneat

ProCal

Lab Software

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Position Summary

• The Contract Associate Quality Specialist is responsiblefor supporting day-to-day Quality Assurance activities at the facility andserves as an integral member of the Quality Systems Centre of Excellence (CoE)Team. This role ensures robust compliance with global quality and cGMPstandards, supports core site quality systems, and actively contributes tocontinual improvement initiatives across the site.
• Operating within a fast-paced environment, the successfulcandidate will apply strong quality systems knowledge to oversee qualityagreement management, support supplier qualifications, manage customercomplaints, and drive thorough root cause identification for deviations, CAPAs,and validation lifecycle activities. Additionally, this role provides criticalQA oversight for analytical and microbiological laboratory operations,equipment/method validation, environmental monitoring compliance, and materialshelf-life/expiry evaluations.
• 11 Month of Contract

Requirements

Key Responsibilities

Quality Systems, Investigations & CAPA

• Deviation Trending & Support: Provide qualityassurance oversight for deviation investigations, process performancemonitoring, and root-cause analysis. Perform routine deviation trending toidentify systemic patterns and drive proactive site improvement initiatives.
• CAPA Management: Apply robust knowledge of qualitysystems to ensure the definition and execution of highly effective Correctiveand Preventive Actions (CAPA).
• Customer Complaint Management: Coordinate, track,and support the investigation of customer complaints. Collaborate withcross-functional technical teams to perform thorough impact assessments,establish root causes, and draft technical complaint investigation reports in atimely manner.
• Annual Reviews: Coordinate and prepare AnnualProduct, Process, and System Reviews to verify ongoing validation status andregulatory compliance.

Analytical & Microbiological QA Support

• Analytical Support & Change Control: Act as the primary QA compliance partner for site analytical and microbiologicallaboratories. Review, technically assess, and approve laboratory changecontrols, including updates to testing specifications, laboratoryinstrumentation, software parameters, and reagents.
• Method Validation & Approval: Review, assess,and approve analytical and microbiological method validation, verification,co-validation, and transfer protocols and reports (e.g., for HPLC, GC, wetchemistry, physical testing, and microbiological assays) to ensure compliancewith global regulatory filings, USP/EP/JP compendial requirements, and ICH Q2guidelines.
• Environmental Monitoring (EM) & Micro Oversight: Provide Quality Assurance oversight for the site’s Environmental Monitoring,microbiological control. Review EM data trends, support the investigation ofcleanroom environmental or utility out-of-limit/out-of-trend (OOT) events, andparticipate in aseptic qualification activities, media fills, and contaminationcontrol assessments.
• Material Expiry & Retest Evaluation: Evaluateraw material, intermediate, and API stability data to support material expiryextension or retest date recalculation requests. Ensure all material expiryevaluations are scientifically justified, fully documented, and compliant withsite regulatory files.
• Agreement Management: Act as the dedicated sitecoordinator for Quality Agreements (QAs) and Change Agreements (CAs).
• Oversight & Maintenance: Maintain and oversee the site's QA and CA registers, execute periodic reviews of active agreements,and author or revise agreements as regulatory or business needs dictate.
• Supplier Qualification Support: Support the site'sSupplier Qualification program. Help manage the approved vendor register,evaluate supplier assessment questionnaires, draft supplier quality agreements,and coordinate risk assessments for new or modified materials and serviceproviders.

SAP Master Data & Governance

• Data Stewardship: Support SAP Master Datacreation, standard updates, and strict data governance activities to maintainoperational compliance and system integrity.
• Inventory Status & Expiry Control: Partnerwith warehouse and supply chain teams to govern material status changes, expirydate updates, and quarantine locks within SAP following material expiryevaluations.

Validation, Equipment & GMP Compliance

• Equipment Validation Oversight: Provide QualityAssurance oversight, review, and approval for equipment, utility, and facilityqualification/validation activities. Evaluate and approve IQ/OQ/PQ protocols,validation execution data, and final reports (utilizing electronic validationsystems such as Kneat and ProCal) to ensure compliance with cGMP and dataintegrity principles.
• Submission Support: Support regulatorysubmissions, market renewals, and GMP declarations by compiling, reviewing, andproviding timely and accurate Quality Assurance inputs.
• Validation Guidance: Provide QA guidance oncompliance requirements to maintain validated status across systems andprocesses, including active participation in product and process riskassessments.

Audits, Walkdowns & Metrics

• Lead/Support Audits: Act as a lead or team auditorfor internal GMP walkdowns and scheduled site audits to maintain inspectionreadiness.
• Metrics & Reporting: Support the development,compilation, and critical analysis of key site quality metrics. Draftcompliance summaries and prepare reporting materials for site Quality Councilsand cross-functional leadership teams.

Qualifications & Skills

Education

• Degree or postgraduate qualification in Chemistry,Microbiology, Biology, Science, Pharmacy, Engineering, or a related technicaldiscipline.

Experience & Technical Knowledge

• Industry Experience: (3+) years of Quality Assurance,Quality Systems, or Laboratory QC/Microbiology experience in a highly regulatedGxP pharmaceutical or biopharmaceutical manufacturing environment.
• Laboratory & Microbiology Compliance: Directexperience reviewing analytical/microbiological laboratory investigations(OOS/OOT), laboratory change controls, stability protocols, environmentalmonitoring data, or sterility assurance parameters.
• Method Validation Expertise: Demonstrated,practical knowledge of method validation, verification, and transfer principles(e.g., executing or reviewing protocols in line with ICH validationparameters).
• Environment Monitoring: Practical knowledge of,microbiological testing methodologies (e.g., bioburden, endotoxin, growthpromotion), environmental monitoring programs.
• Equipment & Validation Knowledge: Practicalexposure to reviewing equipment qualification protocols, change controls, orengineering validation packages (ideally utilizing systems like Kneat andProCal).
• Core QA Competencies: Proven understanding ofQuality Agreements, Change Agreements, Supplier Qualification practices,Customer Complaint handling, and SAP Master Data governance.
• Continuous Improvement: Demonstrated knowledge andpractical application of Lean principles or Continuous Improvementmethodologies (e.g., Kaizen, Six Sigma, Right-First-Time).

Core Competencies

• Communication: Demonstrates excellent written andverbal communication skills; possesses the ability to convey complex quality,microbiological, and technical validation concepts clearly, accurately, andappropriately across diverse operational, laboratory, and leadership audiences.
• Teamwork & Collaboration: Collaborateseffectively within cross-functional teams to support Right-First-Time (RFT)performance across site operations; willingly shares knowledge and resources tosupport mutual goals.
• Decision Making: Exercises sound,compliance-driven judgment utilizing data-driven insights; makes well-informeddecisions that balance compliance standards with operational requirements.
• Adaptability: Responds quickly and effectively tochanging site priorities, regulatory landscapes, and project timelines;comfortable operating in a dynamic contract environment.
• Work Standards: Demonstrates an uncompromisedcommitment to high standards of accuracy, precision, and completeness withstrong attention to detail.