Proclinical is advertising a vacancy for a Lab Tech II, QC Cell Biology position with a leading pharmaceutical company that provides bioanalytical and metabolism services to the pharmaceutical, biotech, and agrochemical industries. This exciting organisation is seeking for the Lab Tech to join their team in Pennsylvania.
The Lab Tech II, QC Cell Biology will perform assays according to testing records and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines, and Standard Operating Procedures (SOPs). They will complete test methods and other required documentation and perform laboratory maintenance duties according to GLP, cGMP, CFR, PTC guidelines, and SOPs.
Job Responsibilities:
- Maintaining cell cultures in accordance to SOPs and testing records.
- Conducting assays and lab procedures as outlined in testing record and regulatory guidelines.
- Accurately completing testing records and other required documentation according to Good Documentation Practices (GDP).
- Performing assays using appropriate laboratory techniques.
- Reporting observations of ongoing tests to Technical Reviewer or Laboratory Manager.
- Communicating with supervisors and other colleagues' daily lab activities.
- Preparing reagents and restocking labs with supplies.
- Maintaining equipment's cleaning logs.
- Aiding in the training of new employees.
- Maintaining, passaging, and seeding cells.
- Training on departmental assays such as in vitro, detection, and retroviral assays.
- Initiating and writing nonconformances.
- Participating in R&D projects and assay validations.
- Performing testing in BSL2+ laboratory.
- Working on routine assignments per written procedures, where the ability to recognise deviation from accepted practices is required.
- Contributing to the overall operations and to the achievement of departmental goals.
- Performing job specific tasks in compliance with applicable Regulations, International Standards, Policies, and Standard Operating Procedures.
Skills and Requirements:
- A University Degree in a Biological Sciences or science related field or equivalent experience.
- 1-2 years of relevant experience, or equivalent.
- A thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- Must be able to work in Lab setting with Biohazards /various Chemicals.
- Must be able to wear appropriate PPE.
- Must be able to work in environment with variable noise levels.
- Ability to stand /Sit/walk for long periods of time.
- Ability to Lift 20 lbs routinely.
- Ability to crouch, bend, twist, and reach.
- Clarity of Vision.
- Ability to identify and distinguish colors.
- Must be able to perform activities with repetitive motions.
- At least five years of experience working in Pharmacovigilance Quality Assurance.
- Experience working with a CRO is desirable, but not a pre-requisite.
- Experience in hosting customer audits and regulatory inspections is an advantage, but not a pre-requisite.
- Strong knowledge of pharmaceutical research, development processes, and regulatory environments.
- A detailed working knowledge of quality assurance processes and procedures.
- Demonstrable experience of maintaining up-to-date knowledge of regulatory requirements, including changes in requirements and expectations.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Director Level.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at +44267 983 0134 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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