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Quality Assurance Engineer
2 months ago
Company Overview:
Trinity Consultants - Advent Engineering is a leading engineering and consulting firm dedicated to delivering exceptional services to the pharmaceutical and biotechnology sectors. With a strong presence across the Eastern US and Canada, we specialize in comprehensive solutions for facility design, process engineering, and quality system projects.
Position Summary:
The selected candidate will collaborate with a team of Compliance Specialists to manage the creation, tracking, and resolution of Corrective and Preventative Actions (CAPAs) related to facility maintenance. The ability to work effectively within cross-functional teams is highly valued.
Key Qualifications:
- Bachelor's degree in Engineering, Biology, or a related field.
- A minimum of 5 years of relevant experience in a Quality Assurance or Compliance environment.
Essential Responsibilities:
- Act as a liaison between the Facilities Department and onsite quality and regulatory teams to implement CAPAs.
- Oversee and engage in the Facilities Department CAPA Program, ensuring timely execution in accordance with established procedures and regulatory standards.
- Monitor and track CAPAs assigned to the facilities department on a daily basis.
- Manage all aspects of CAPA ownership, including facilitating cross-functional meetings, processing extension requests, and submitting evidence to Quality Assurance.
- Initiate and manage requests and workflows within the Computerized Maintenance Management System.
- Participate in weekly meetings to discuss CAPA progress, address obstacles, and manage agenda items.
- Conduct CAPA Effectiveness Checks, analyzing relevant data and documenting findings in reports.
- Provide training and support to Facilities personnel on regulatory and quality topics, including documentation procedures and software usage.
Desired Skills:
- Excellent verbal and written communication skills.
- Strong organizational abilities to manage multiple projects simultaneously.
- Proficient data analysis skills, particularly in Excel and performance metrics.
- Solid understanding of Good Manufacturing Practices (GMP) and preventative maintenance principles.
- Familiarity with a wide range of equipment utilized in pharmaceutical production, such as bioreactors, chromatography skids, and air handlers.
Commitment to Diversity:
We are dedicated to fostering an inclusive and diverse workplace. We encourage all interested candidates to apply and are committed to providing an accessible interview experience. Please inform us of any accommodations needed during the interview process.
Application Process:
Applications will be reviewed until the position is filled. Only candidates selected for an interview will be contacted.