TECHNICAL OPERATIONS, PHARMACEUTICAL GMP ELKTON, VA 100% Onsite.
Project Description:
Achieve Safety, Quality, and Environmental compliance excellence in all assignments.
Prepare, track and report on component, equipment, and raw material supplier issues/ inquiries.
Leading and conducting technical investigations and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation.
Assessing vendor change notifications for product, process, and regulatory impact.
Communicating with vendors to obtain compliance and validation documentation.
Work closely with procurement and materials management to ensure material control compliance.
Writing, reviewing, improving documentation for technical and regulatory compliance excellence.
Contributing to process and equipment safety reviews and performance qualifications.
Assess viable alternate source(s) for components by reviewing functionality and safety requirements to ensure that components can be integrated into the process.
Assist with training of operations and maintenance personnel as needed on GMP equipment.
Current example are the FIT units and general integrity test setup and troubleshooting.
Position is very change control focused.
Required Skills:
B.S. Or M.S. Degree in biology, biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, chemistry, integrated science, or mechanical engineering.
2+ years of relevant industrial experience required.
Must have some type of change management experience (systems, controls, etc.).
Experience in a GMP environment/knowledge of GMP principals.
Strong problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.
Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
The ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.
Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.
Willingness to work as a contributing member of a dynamic team of individuals.
Single Use Component/Filtration experience.
Manufacturing environment experience.
Experience working in a cGMP environment.
Technical writing skills.
Supplier management or supply chain experience.
Production/shop floor experience.
Experience working w/suppliers (supplier management, supplier interaction).
Sterile/aseptic processing experience .
Past experience with change management, manufacturing, Quality ops .
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00204
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
