* Industry Pharma/Biotech/Clinical Research
* Work Experience 1-3 years
* City Carlow
* State/Province Carlow
* Country Ireland
Job Description
About PSC Biotech
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 to 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 through learning & development, in-house training, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients’ expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
* As QC Bioassay Analyst, you will perform and review a range of techniques such as immunoassays, cell-based potency bioassays, and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release. Reporting to the Bioassay Manager/Associate Director, you will ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety, and reliable supply to our customers.
* Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Requirements
Responsibilities:
* Work as directed by the Bioassay Manager/Associate Director, according to Company safety policies, cGMP, and cGLP.
* Drive compliance with our global policies, procedures, guidelines, and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
* Develop, implement, and maintain procedures that comply with appropriate regulatory requirements.
* Ensure that all Quality Systems within the department are adhered to on a daily basis.
* Operate as part of the QC team performing the allocated testing and laboratory-based duties.
* Ensure timely completion of all assigned data processing and reviewing.
* Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.
* Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, and reports in support of method validation/verifications and equipment qualifications.
* Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations, etc.
* Peer review testing documentation and ensure data integrity compliance and QC Right First Time KPIs are achieved.
* Where applicable, review, approve, and trend test results.
* Participate in the laboratory aspects of OOS investigations.
* Provide support with audit/inspection requirements to ensure department compliance/readiness.
* Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
* Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's, etc.
* Work collaboratively to drive a safe and compliant culture.
* May be required to perform other duties as assigned.
Skills & Knowledge:
Technical:
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Knowledge of cGMP.
* Laboratory Quality Systems.
* Proficiency in Microsoft Office and job-related computer applications required.
* Understanding of Lean Six Sigma Methodology preferred.
* Immunoassay and cell culture experience preferable.
People:
* A great communicator, decisive decision-maker with a proven ability to deliver excellence.
* Ability to participate in highly effective teams.
* The desire to continuously learn, improve, and develop.
* Strong leadership and interpersonal skills.
* Willingness to support the team and a strong focus on delivering excellence.
* High personal integrity, credibility, energy, and flexibility.
* Model the leadership behaviors and use the MPS principles to achieve success.
* Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
Education:
* Bachelor’s Degree or higher preferred; ideally in a science-related discipline.
Reports to: Bioassay Manager / Associate Director
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