Job Summary:
In this role, you are responsible for executing testing for both internal and external customers in a cGMP environment.
Essential Duties and Responsibilities:
- An expert in basic established techniques, equipment, and/or test methods while following standard operating procedures (SOPs).
- Proficient with complicated techniques, equipment, and/or test methods.
- Independently complete projects from initiation through completion.
- Actively participate in and complete all appropriate training tasks in a timely manner.
- Provide training on basic established techniques and/or test methods.
- Author basic work instructions, SOPs, and qualification documentation.
- Participate in and complete simple lab investigations, OOS, and OOT as required.
- Meet individual and departmental goals and metrics.
- Make rational and sound decisions at an individual level.
- Other duties as assigned.
- Adhere to established laboratory safety procedures.
- Follow required cGMP regulations and internal QA procedures.
- Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
- Willingness to learn and apply new analytical techniques.
Basic Qualifications:
- BS in biology, chemistry, or other relevant scientific field.
- Minimum 2 years in a related field and a cGMP environment.
Preferred Knowledge, Skills and Abilities:
- cGMP
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
Travel Requirements:
- Must be able to travel up to 5% of the time
Physical and Mental Requirements:
- Job-related activities that require a physical activity such as standing in laboratory environment.
- Effective dexterity to operate objects, tools, or controls and reach with hands and arms.
- Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment.
- Employee may be required to lift heavy objects (up to 25 lbs.) without assistance.
- Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g. Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures).