What are the responsibilities and job description for the Manufacturing Specialist position at Randstad Life Sciences US?
Manufacturing Specialist
1 Year (Extendable)
Thousand Oaks, CA
Max PR : $43-47 / hr
100% ONSITE ROLE SUPPORTING FACILITY.
HIRING NOTES : Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Why is the Position Open?
Planned Project
Top 3 Must Have Skill Sets :
Clear communicator, Cross functional team leader, project management, problem resolution
Day to Day 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
Possible Extension : Red Flags :
No prior project experience, no prior work experience
Interview Process :
2, video conference
Summary
Part of the Drug Product New Product Introduction Team at Company Thousand Oaks. This building is a clinical and commercial syringe and vial filling facility supporting patients worldwide.
Responsibilities include, but are not limited to :
New Product Introductions (NPI) program management and non-capitol project management. The individual will be responsible for leading projects of diverse subjects and complexity and have proven strong communication and collaborative capabilities, both within and outside of the immediate team. The Manufacturing Specialist will successfully inform, influence, and assign accountability to members of cross-functional teams that include : Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Job Responsibilities :
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 Building 20 Manufacturing Facility
Timely closure of change control records in relation to procedural guidance and / or disposition timelines
Represent Building 20 Manufacturing as the receiving site for incoming Technology Transfers / New Product Introductions into Building 20
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
Champion safety and compliance at all times
Preferred Qualifications :
Master’s Degree
Bachelor’s Degree in life sciences or engineering
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
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Manufacturing Specialist?
Sign up to receive alerts about other jobs on the Manufacturing Specialist career path by checking the boxes next to the positions that interest you.
