What are the responsibilities and job description for the JT585 - MANUFACTURING SR. ASSOCIATE position at Quality Consulting Group?
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Managing and owning Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs) in support of the B7 restart of Epogen production.
- Participate in continuous improvement initiatives and utilize project management skills to achieve operational excellence.
- Work in a cross-functional team and collaborate with various stakeholders to ensure quality and compliance.
- Lead and execute CAPAs and EVs related to Epogen production, ensuring timely completion and documentation.
- Identify and implement continuous improvement opportunities to enhance process efficiency, quality, and safety.
- Use project management tools and methodologies to plan, monitor, and report on project progress and outcomes.
- Communicate effectively with internal and external partners, such as quality, engineering, validation, regulatory, and suppliers.
- Adhere to all applicable policies, procedures, and standards, such as cGMP, SOPs, and EHS.
- supporting Risk management
- Supporting Safety Culture
Qualifications:
- Bachelor’s degree and three years of Manufacturing or Operations experience
- Degree in engineering, science, or related field, or equivalent combination of education and experience.
- Able to manage and owning Corrective and Preventative Actions (CAPAs)
- Prefer some experience with CAPA and EV ownership and execution, preferably using Trackwise or similar quality system.
- Strong analytical, problem-solving, and decision-making skills.
- Ability to work independently and collaboratively, with a high level of initiative and accountability.
- Excellent verbal and written communication skills, with attention to detail and accuracy.
- Experience with project management tools and techniques, such as MS Project, Agile, Smartsheet.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
