Proclinical is advertising a vacancy for a QA Specialist position with a leading pharmaceutical, biopharmaceutical, and medical device capability company. The organisation provides comprehensive platform capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, and cell and gene therapy R&D. The QA Specialist will join this company in their office in Minnesota. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
The primary responsibilities of the Quality Specialist include ensuring GLP studies, GMP testing, and GMP manufacturing activities are executed in accordance with the appropriate regulatory bodies and internal procedures. In addition, the Quality Specialist is responsible for performing internal audits, ensuring timely completion of investigation documents, and providing training to peers on systemic requirements.
Job Responsibilities:
- Performs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines, and SOPs using appropriate laboratory techniques for the lab group assigned to.
- Performs laboratory support functions (e.g. materials stocking function) to help ensure lab is operational and contributes to the overall operations and to the achievement of departmental goals and objectives.
- Adheres to and understands the importance of Good Manufacturing Practices, Good Laboratory Practices, and standard operating procedures, including Good Documentation Practices.
- Has a working knowledge of the regulatory compliance requirements for the testing of biologics.
- Performs all Standard Operating Procedures (SOP's) and revisions, and Reagent Preparation Records as needed to accurately reflect testing procedures.
- Reviews data entries in lab notebooks, instrument logbooks, and lab cleaning forms to comply with regulatory requirements.
- Creates testing documents and performs revisions to existing documents (e.g., BRs, RPs, SOPs) following the DCR process.
- Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance.
- Demonstrates innovative technical knowledge and significantly contributes to the overall production efficiency.
- Supports technical transfer of assays from client to Technical Development to Operations; supports additional research level testing activities.
- Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
- Works on routine assignments per written procedures, as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations.
- Works with minimal supervision from supervisor and/or Technical Reviewer.
- Completes all requisite site-specific and job-specific training (e.g., Bloodborne Pathogens, Safety, GDP, and Radiation Safety).
- Contributes to the achievement of company and departmental goals and objectives.
- Analyses scientific data with accuracy and precision, critical at time of processing.
- Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP's) and Batch Records and that training records for junior staff are accurate and current.
- Possesses sound scientific knowledge and understanding of molecular testing assays and uses this skill set to routinely monitor testing processes and recognize potential process issues as they arise.
- In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of testing processes and procedures.
- Authors and reviews non-compliance reports, laboratory investigation reports, SOP revisions, and Batch Record revisions to ensure documents are accurate and complete.
- In conjunction with area management participates in the annual employee evaluation process.
- Functions as area operational leader providing both technical leadership as well as leadership to staff in area with respect to work assignments and schedules.
- Provides support to Area Management in resource allocation and scheduling.
- Actively contributes to training, report generation and documentation.
- Provides training and operational guidance to junior staff and also serves to mentor junior staff in molecular techniques.
- Works under supervision from supervisor or senior personnel.
- Contributes to the overall operations and to the achievement of departmental goals.
Skills and Requirements:
- A university level degree.
- Demonstrable experience in a related field or similar capacity.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
- 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.
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 Mike Raletz at +267-428-7770 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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