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Quality Assurance Specialist
2 months ago
DPS Engineering is seeking a Quality Assurance Specialist to provide essential quality oversight and expertise, ensuring technical success while adhering to a robust Quality System that meets global regulatory standards. The ideal candidate will possess substantial experience in quality oversight or manufacturing within clinical and/or commercial product environments. This role requires close collaboration with colleagues and supervisors in Manufacturing, as well as cross-functional partnerships with Quality Control, Digital, and Manufacturing Science and Technology teams.
Key Responsibilities
- Review and oversee both electronic and paper batch record documentation.
- Draft and evaluate Standard Operating Procedures (SOPs), policies, and batch production/testing records to guarantee compliance with regulations and cGMP operations.
- Collaborate closely with peers for expedited review of batch-related documentation.
- Ensure adherence to current good manufacturing practices, standard operating procedures, and accurate manufacturing documentation. Establish and maintain written procedures for clear documentation of equipment operation and process instructions.
- Monitor process operations to confirm compliance with established specifications.
- Assist in investigating procedural deviations.
- Oversee the execution of Corrective and Preventive Actions (CAPAs), deviations, and change controls in support of manufacturing processes.
- Review minor manufacturing deviations.
- Develop batch records, SOPs, and training materials as necessary.
- Exhibit a comprehensive understanding of standard manufacturing compliance, quality disposition, and quality system review.
- Utilize expertise to enhance operational efficiency.
- Engage in quality oversight of manufacturing through real-time observations of operational activities.
- A minimum of 5 years of experience in Quality Assurance or Manufacturing within a GMP environment, complemented by a Bachelor's Degree in Biology, Chemistry, Chemical Engineering, Biomechanical Engineering, Bioengineering, Biomedical Engineering, Biochemistry, or a related field.
- Demonstrated success in a dynamic production environment, preferably within a biotech or pharmaceutical company adhering to GMP or GLP standards.
- Proficient in collaborating effectively with peers, supervisors, and cross-functional support teams.
- Exceptional written and verbal communication skills, along with strong organizational abilities.
- Able to work under general direction to plan, coordinate, and ensure the completion of engineering team deliverables.
- Strong interpersonal, teamwork, and leadership skills are essential.
- Participates in defining assignment objectives and plans, schedules, and organizes activities to achieve milestones.
DPS Group is a global EPCM firm providing comprehensive solutions in the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) sectors. We are committed to delivering successful projects with a client-centric approach and a personal touch across various market sectors, including Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer, and our employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate in employment opportunities or practices based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other characteristic protected by applicable law.
