QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, youll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Set up meetings with stakeholders to gather impact assessments as a result of new product introductions
- Own change controls in Trackwise software
- Resolve project timeline issues and influence discussions toward problem resolution
- Track and clearly communicate NPI statuses
- Manage cross functional teams that do not report directly to you
- Succinctly communicate verbally while leading meetings and in writing to staff and leadership
- Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right-First-Time approach.
- Strong project management skills, with prior project experience a must
- Lead meetings with cross functional teams to align on change scopes and impact assessments when new products are introduced to theManufacturing Facility
- Timely closure of change control records in relation to procedural guidance and/or disposition timelines
- Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities
- Presenting records and business processes to a variety of audiences, including auditors and inspectors
- Participating/leading Continuous Improvement Transformation activities
Qualifications:
- Bachelor's degree in life sciences or engineering
- 5 years of related experience
- Experience using Trackwise software
- Prior experience leading cross-functional teams to align on CAPAs and closing deviations
- Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP Formulation, DP Filling, Inspection
- Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
- Demonstrated technical writing skills
- Demonstrated ability to work in a team
- Deviations Knowledge
- Administrative Shift
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.
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