Lab Technician (Biohazardous Samples)
- Individual will work in Client’s Operations Quality Assurance organization investigating return samples for medical device and combination product complaints and inquiries.
- Responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system.
- Interface with internal Client customers regarding product complaints.
Responsibilities may include interaction with various third parties.
Responsibilities
- Work in a laboratory setting wearing Personal Protective Equipment (e.g., gloves, lab coat, safety glasses).
- Product complaint documentation, investigation, and review of all non-medical complaint content.
- Responsible for reviewing complaints that involve a non-medical quality related problem.
- Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP. Responsible that complaint data meets all regulatory requirements.
- Comfortable working with sharps (e.g., needles) that are potentially biohazardous.
- Identification of potential reportable events and notification to appropriate functional groups and management.
- Reviews documents and recommends changes to help ensure team objectives are met.
- Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes. Takes initiative to be a key player in team activities.
- Completes special projects in resourceful and effective ways to support overall group needs and requirements.
Qualifications
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- A bachelor’s degree in technology or scientific background preferred or 1-2 years of relevant work experience.
Notes:
Are you open to look at candidates willing to relocate? No
What are the top 3-5 skills requirements this person should have?
- Able to use time efficiently and effectively to complete workload
- Good Organizational skills
- Effective written and verbal communication skills
- Works and collaborates well on a team
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
- Lab experience, bio-hazardous lab
- Experience with pharmaceutical or medical devices
- Pharmaceutical experience
- Complaint investigation experience
What type of environment is this person working in?
- Biohazardous lab, PPE (Safety glasses, Labcoat, gloves) required
- Comfortable working with Sharps (needles) may contain biohazardous material
What is the expected work schedule? Is overtime offered or required? If yes, how many hours?
- First shift, Overtime is offered
Does this position offer the ability to work remotely on a full or hybrid basis?
- This is an onsite laboratory role