QC BioAnalytical Sciences

1 day ago


Dublin, Ireland PSC Biotech Ltd Full time
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 point 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. 

QC BioAnalytical Sciences

MUST haves: Cell based potency bioassays min experience, Cell culture, GMP/GDP Elisa

  • This job specification outlines the general responsibilities associated with the role of QC BioAnalytical Sciences – Senior Associate on the **** Manufacturing site. 
  • This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues. 
  • The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). 
  • The role also represents the QC unit by liaising with internal and external customers.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.

Requirements
Key Responsibilities

  • Experience in a wide variety of analytical techniques including but not limited to cell based- Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays) and Aseptic Technique. Experience with liquid-handling robots is also preferable.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Participate in the peer review of analytical data.
  • Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
  • Lead training of staff on technical aspects of job as required.
  • Develop, revise and implement procedures that comply with appropriate regulatory requirements.
  • Qualification of analytical equipment and related testing functions.
  • Participate in Analytical Method Transfers.
  • Compliance with Standard Operating Procedures and Registered specifications.
  • Ensure the laboratory is operated in a safe manner.
  • Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
  • Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
  • Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
  • Participate in regulatory agency inspections as required.
  • Plan and implement procedures and systems to maximise operating efficiency.
  • Manage and contribute to the achievements of department productivity and quality goals.


#LI-XA1

Requirements
Knowledge/Skills: Strong Project Management and organizational skills, including ability to follow assignments through to completion. Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills. Escalate issues professionally and in a timely manner. Ensures compliance within regulatory environment. Demonstrated ability to work independently and deliver right first-time results under minimal direction. Experience participating in and leading cross-functional teams. Experience in managing multiple, competing priorities in a fast-paced environment. Relevant Experience: Bachelor’s degree in a Science or Engineering discipline. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage. #LI-XA1

  • Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho 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...


  • Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho are we?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...

  • Lab Technician

    1 month ago


    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho are we?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...

  • Lab Technician

    1 month ago


    Dublin, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout PSC BiotechWho are we?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...


  • Dublin, Ireland PSC Biotech Ltd Full time

    About PSC Biotech Ltd 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...


  • Dublin, Ireland PSC Biotech Ltd Full time

    Job DescriptionAbout PSC Biotech Ltd 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...

  • QC Technician

    2 weeks ago


    Dublin, Ireland Guidant Global Full time

    QC Technician We are looking for experience Quality Control Technician's, to join a busy team in one of Ireland's leading beverage companies. You will have the opportunity to work for a hugely successful company and join a fantastic team of people. About the role As a Quality Assurance Technician, you will play a pivotal role ensuring that all manufactured...

  • Senior QC Associate

    3 weeks ago


    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho 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...


  • Dublin, Ireland PSC Biotech Ltd Full time

    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...

  • QC IPC Shift Chemist

    3 weeks ago


    Dublin, Ireland Cpl Remote Work Freelance Full time

    SK biotek Ireland in partnership with CPL is seeking to recruit a Quality Control IPC Chemist to join the QC Department on a 12 month contract. This position is in the In-Process Control group in QC. This position will involve shift work.Position Description:Reporting to the QC IPC Team Lead, the successful candidate will provide in-process analytical...


  • Dublin, Ireland Gilead Sciences Ireland UC Full time

    Description As a member of the CDS-RWE Analytics group, the RWD Analyst reports directly Head of RWE Analytics and is responsible for the design and conduct of statistical analyses of RWD to assess the value of Gilead therapies and perform data visualization and QCs TFLs to communicate results to internal stakeholders in Real World Evidence. The RWD...


  • Dublin, Ireland PSC Biotech Ltd Full time

    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...


  • Dublin, Ireland Bristol Myers Squibb Irl Full time

    Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...


  • Dublin, Ireland Life Science Recruitment Ltd Full time

    Senior Associate Quality Control NPI RK3535 12 Months Dublin Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role is responsible for one or more of the...


  • Dublin, Ireland PM Group Full time

    Overview We have an immediate requirment for a Health & Safety Advisor (Nights) for a large scale Pharmaceutical Construction project in Co. Dublin. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are focused on growing a sustainable business centred around our people, our clients and trade...


  • Dublin, Ireland PM Group Full time

    Overview We have an immediate requirment for a Cleanroom Package Lead for a large scale Pharmaceutical Construction project in Co. Dublin. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are focused on growing a sustainable business centred around our people, our clients and trade partners. We...

  • EHS Advisor

    2 weeks ago


    Dublin, Ireland PM Group Full time

    Overview We have an immediate requirment for a EHS Advisor (Weekend Shift) for a large scale Pharmaceutical Construction project in Co. Dublin. Who we are PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are focused on growing a sustainable business centred around our people, our clients and trade partners....

  • Quality Engineer

    3 months ago


    Dublin, Ireland Embecta Full time

    embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...


  • Dublin, Ireland Pfizer Ireland Pharmaceuticals Full time

    ROLE SUMMARY The mission of the PGS Digital Creation Centre Team is to revolutionise processes and elevate experiences, propelling Pfizer Global Supply (PGS) towards exceptional outcomes. As the driving force behind the digital transformation of various operations including the shop floor, quality control, quality assurance, engineering, and environmental...

  • Food Safety

    4 months ago


    Dublin, Ireland Musgrave Full time

    Summary Job ref: 15437 Job Type: Location: Dublin Contract type: Permanent Closing Date: 9 July 2024 Food Safety & Quality Technical Specialist - La Rousse Foods We are now hiring a Food Safety & Quality Technical Speciliast in our La Rousse Foods Business to cover the eveninng shift 3.30PM - 11PM (Monday -...