QC Associate (Senior) - BioAnalytical Sciences
Posted on :
23-08-2022
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1 Vacancy
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Jobs by Experience
5+ years
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-08-2022
Job Description
Req ID : 1687940
Job Title :QC Associate (Senior) - BioAnalytical Sciences A32000
About the Company:
Our client is a Multinational Biopharmaceutical company with more than 20,000 employees worldwide and approximately 500 workers in its D n Laoghaire (co. Dublin) facility, which is a 37,000-square-metre aseptic operations facility with freeze-dry product (lyophilization) and liquid vial-filling capabilities.
Its Irish site specializes in secondary manufacturing activities formulation, fill, and packaging, and also includes a bioprocessing suite and laboratories. The local team is currently engaged in one of the largest and fastest technology transfer programs in the company s history. Make a difference in the lives of others, working at the forefront of biotechnology with the top minds in the field.
Job Summary:
This job specification outlines the general responsibilities associated with the role of QC BioAnalytical Sciences Senior Associate on the company 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.
Job Duties:
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.
Requirements
MUST have: Cell based potency bioassays min experience, Cell culture, GMP/GDP Elisa
Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
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.
Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
Excellent written and verbal communication skills
*** No Visa Processing ***
Benefits
Benefit from Independent Solutions ethical principles!
We look after our team, we know the business, we have been working in the sector >20 years. We are not a recruitment agency
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
We offer attractive rates - competitive margins compared to our competitors
Payment on time and in full
We continue to partner and grow our client base and thereby ensure that we have a continuous supply of High-Value Projects
We work for you!
MUST have: Cell based potency bioassays min experience, Cell culture, GMP/GDP Elisa Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline. Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory. 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. Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating. Excellent written and verbal communication skills *** No Visa Processing ***
Employment Type
Full Time
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