Quality Specialist I

Engineer I

Location: 2778 South East Side Highway, Elkton, VA Rate: $34/HR on W2

Qualifications:

• B.S. or M.S. degree in biology, biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, computer science, integrated science, or related disciplines and 0-3 years of relevant industrial experience. • Shift Hours: Primarily ~8am – 5pm Mon-Fri, occasionally working longer or until 22:30 (~2-3 weeks/year), Beta Lactam required so no known allergy The successful candidate must have:

• Excellent academic record
• Strong verbal and written communication skills, team skills, personal character, and ethics
• Strong problem solving skills and a hands-on approach to problem solving, with a bias towards going to see problems for oneself in the field.
• 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.
• Strong desire to succeed and to help others to do the same.

Must Have Experiences:

• Experience working in a cGMP environment • Work, co-op, or internship experience in industry

Responsibilities:

Providing technical support for sterile manufacturing processes in the form of data analysis, troubleshooting, problem-solving, report writing, and shop-floor support • Supporting change control implementation • Collaborating with cross-functional teams across levels • Learning new processes and procedures • Performing shift work as needed (expected to be minimal) • Conducting technical investigations and analyses • Recommending and implementing corrective and preventative actions, and helping lead reduction of atypical events • Writing, reviewing, and improving procedures for operation of equipment and processes • Contributing to process and equipment safety review

Comments/Special Instructions 50/50 floor/desk work. Mixture of doing investigations, floor support, desk work Tech Ops group Softskills- Not afraid to speak up, ask questions, collaboration mindset (flexibility), think outside the box Heavily Preferred- Relevant Co-ops and/or manufacturing experience. Capa, deviation, technical writing, change control all nice to have