Quality Control Snr Associate

4 weeks ago

Dublin, Ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 5+ years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

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

Quality Control Snr Associate

Job Summary:

· Under minimal supervision, responsible for oneor more of the following activities in QC including analytical testing,characterization, sample and data management.

· Contributes to team by ensuring the quality ofthe tasks/services provided by self

· Contributes to the completion of milestonesassociated with specific projects or activities within team.

· This role will support QC and manufacturingoperations, as such some extended hours and weekend work flexibility may benecessary as required.

Requirements

Primary Responsibilities:

· QC Representative for NPI activities and routineProduct meetings

· Assist with activities related to QC projectsand/or QC tasks within Site projects.

· Plan and perform non-core testing related to NPIactivities.

· Manage all sample management activities relatedto NPI activities throughout the site.

· Create/own and approve protocols, sample plans,SOP and documentation related to NPI.

· QC Representative responsible for MethodValidation and Transfers co-ordination and readiness

· Responsible for their own training and safetycompliance.

· Sample shipments and temperature monitoringactivities for NPI activities.

· LIMS data coordination of non-core (NPI)activities.

Specific Job Duties:

· With a high degree of technical flexibility,work across diverse areas within QC

· Plan and perform analyses with great efficiencyand accuracy.

· Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.

· Report, evaluate, back-up/archive, trend andapprove analytical data.

· Troubleshoot, solve problems, and communicatewith stakeholders.

· Initiate and/or implement changes in controlleddocuments.

· May train others as necessary

· Participate in audits, initiatives and projectsthat may be departmental or organizational in scope.

· Write protocols and perform assay validation andequipment qualification/ verification.

· Introduce new techniques to the lab, includingmethod transfers, reports, validations, and protocols.

· May contribute to regulatory filings.

· May conduct lab investigations as necessary.

· Evaluate lab practices for compliance on acontinuous basis.

· Approve lab results.

· May represent the department/organization onvarious teams.

· May interact with outside resources.

· Create APPX data files and randomisation memo tofacilitate data analysis.

· LIMS data coordination of commercial and importtesting on site where applicable.

· May provide technical guidance. May contributeto regulatory filings.

· May represent the department/organization onvarious teams. May train others.

· May interact with outside resources.

Basic Qualifications & Experience:

Qualifications:

· 2-3 years of biopharmaceutical QC experience orrelated quality control or GMP laboratory experience in the pharmaceutical ormedical device industry.

· Strong background in Chemistry and Analyticaltesting is required.

· Experience with regulatory compliance in cGMPmanufacturing and testing of pharmaceutical products.

Knowledge:

· Understanding and application of principles,concepts, theories, and standards of GMP QC analytical laboratories.Deepens technical knowledge through exposureand continuous learning.

· Knowledge of related regulatory/industryconsiderations, compliance issues and/or scientific discovery

Problem Solving:

· Applies analytical skills to evaluate andinterpret complex situations/ problems using multiple sources of information.

· Trend data

· Anticipates and prevents potential problems.

Skills:

· Take initiative to identify and drive improvements.

· Communication skills (verbal and written) at alllevels.

· Strong Technical writing skills for GMPdocumentation (e.g. investigations, procedures, change controls)

· Escalate issues professionally and on a timely basis.

· Decision making

· Teamwork and Coaching others

· Teamwork and Coaching others

· Auditing documentation and operation process

· Demonstrated ability to work independently anddeliver right first-time results

· Work is guided by objectives of the departmentor assignment.

· Refers to technical standards, principles,theories, and precedents as needed.

· May set project timeframes and priorities basedon project objectives and ongoing assignments.

· Recognizes and escalates problems.

· Working knowledge of aseptic compliance withinthe manufacturing environment and demonstrated leadership and communicationskills to communicate requirements to colleagues.

· Auditing documentation and operation process

· Demonstrated ability to interact with regulatoryagencies.

· Bachelor’s degree in a Science related field isrequired.

· 5+ years of biopharmaceutical QC experience orrelated quality control or GMP laboratory experience in the pharmaceutical ormedical device industry,

· Experience with regulatory compliance in cGMPmanufacturing and testing of pharmaceutical products.

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