Location: Carlsbad, CA

Qualifications:

• Bachelor’s degree in Science is a must.
• 3-4 years working in a GXP or ISO regulated environment.
• 1-2 years in a Quality Assurance related role.
• Working experience in internal or supplier audits and hosting external audits
• Experience with EQMS or EDMS (MasterControl) preferred
• ASQ certification such as CQA or CQE is a plus.
• Managing, coordinating, facilitating, and implementing quality assurance standards based on applicable FDA, ICH and ISO requirements experience

Duties & Responsibilities:

• Development, implementation, management and integration of a Quality Management System (QMS)
• Execute routine Document Control activities per KLS SOPs, QMS, and applicable regulatory requirements.
• Write and revise Quality SOPs, and other related procedures.
• Maintain the Training Program and conduct employee training on applicable Quality SOPs, regulatory requirements, and ISO/ICH standards
• Conduct supplier assessments and routine/qualification audits
• Participate in the initiation, documentation, and management of quality events
• Participate in and support the implementation of the EQMS system

Job Type: Full-time

Salary: Up to $36.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year
• 2 years
• 3 years
• 4 years

Schedule:

• Monday to Friday

Work setting:

• In-person

Application Question(s):

• How many years in a Quality Assurance related role in a laboratory/pharma industry?
• Do you have working experience in internal or supplier audits and hosting external audits?
• Are you amenable to work in Carlsbad, CA? Do you have working permit?
• Where is your current location?

Work Location: In person