Tech Ops-4 Lab Ops

Role Summary

Tech Ops-4 Lab Ops

Responsibilities

• Works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze primary, secondary, and tertiary packaging materials. Independently performs inspections and documents results for qualitative or quantitative inspections on packaging materials using techniques that vary from use of visual inspections, handheld equipment such as calipers, to highly modern and automated instrumentation such as Keyence. Conducts peer review (record checking) of laboratory data packets. Participates in training of packaging material inspectors. Provides quality support to warehouse personnel, participates in laboratory investigations, and communicates non-conformance investigations via the SCAR process.

Qualifications

• Required: High School Diploma or GED
• Required: 6+ years of experience
• Required: Certifications in the relevant areas, if applicable
• Required: Ability to write clear technical documents
• Required: Good organizational and time management skills
• Required: Proficiency in Microsoft Office
• Required: Experience with laboratory equipment and procedures
• Required: Knowledge of Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
• Preferred: Bachelor's Degree
• Preferred: Pharmaceutical quality control and stability experience
• Preferred: Prior experience as a RAAC and LIR author
• Preferred: Prior experience interacting with suppliers
• Preferred: Effective problem-solving skills
• Preferred: Strong analytical skills
• Preferred: Strong attention to detail

Skills

• Technical documentation writing
• Laboratory techniques and instrumentation
• Quality systems and compliance
• Data analysis and record review
• SCAR process/issue investigation

Education

• High School Diploma or GED (required)
• Bachelor's Degree (preferred)

Additional Requirements

• Physical/Mental Requirements: Laboratory and office work requiring walking, standing, and sitting throughout a shift. Lifting of items less than 25 lb.
• Non-standard Work Schedule: This is a first shift position which may require occasional weekend support. There is no routine travel associated with this position.