What you need to know
You will work a QC Reviewer for our client, a highly successful and established Pharmaceutical company in Co. Westmeath.
As a QC Reviewer you will monitor the quality of laboratory data and reports. Review chromatographic data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluate data to ensure compliance with analytical methods
This is a Permanent role.
Your new job
Key duties & responsibilities:
- Evaluates laboratory data for compliance with analytical methods and SOPs.
- Reviews sample results for completeness and accurate representation of the data and report findings.
- Communicates with laboratory staff to proactively address the quality of laboratory documentation.
- Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.
- Trains new QC Reviewers and laboratory staff.
- Conducts SOP review and writing. Conducts consultations for quality records.
- Performs other duties as assigned.
What are we looking for?
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Thorough knowledge of chromatography and divisional SOPs
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Strong verbal and written communication skills
- Strong attention to detail
- Ability to train staff
- Ability to independently review laboratory reports and analytical methods
- Ability to deal with multiple and changing priorities
- Ability to provide clear and concise feedback and/or documentation of results
- Ability to work in a collaborative team environment
Below Is Listed The Working Environment/requirements For This Role
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Apply for this job now or get in touch with Aoife on 090 64 90485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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