Job Information
Quality Consulting Group Specialist Manufacturing in Thousand Oaks, California
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:
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 the Manufacturing 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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