Quality Engineer Remote

Quality Engineer - Remote

Pay Rate Range: $71.42/hr. - $85.71/hr.

Initial Assignment Length: 12 months

Shift/Schedule Details: Standard Business Hours

Location Specifics: 100% remote; Prefer candidates in Eastern or Central time zones (but for the right person, any would be acceptable)

Job Description:

Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes.

Conducts quality control for statistical analyses of testing results and process anomalies.

Ensures that corrective measures meet acceptable reliability standards.

Verifies calibration, maintenance, and repair of instruments as applicable to support the Quality Systems validation program.

May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements.

Responsibilities:

1. Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards.

2. Under direct supervision, assists in preparation, execution, data collection, and reporting of validation studies to ensure the user needs and specifications are consistently met.

3. Prepares validation protocols and test equipment; evaluates validation test data.

4. Prepares reports on completed studies that summarize test results and their conformance to defined acceptance criteria.

5. Assists in developing programs and maintaining standard operating procedures (SOPs)validations.

6. May provide support related to management of procedural documents.

7. Communicates cross functionally regarding needs and status of assigned study activities and project deliverables.

8. Perform other job-related duties as assigned.

Manager's Notes:

Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products, and/or processes.

Conducts quality control for statistical analyses of testing results and process anomalies.

Ensures that corrective measures meet acceptable reliability standards.

Verifies calibration, maintenance, and repair of instruments as applicable to support the Quality Systems validation program.

May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements

Requirements:

Bachelor's degree in sciences or engineering or equivalent combination of education, training and relevant work experience required

3+ years' related quality/validation experience in pharmaceutical manufacturing/a highly regulated industry

In-depth working knowledge of cGMP principles and applications

Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations

Participating in FMEA or RCA/CAPA development teams

Understand regulatory standards, various local, state, and federal laws that apply to the business and where to find information on standards and interpretations

Excellent negotiating, critical reasoning, decision-making, and problem-solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects

Strong project management and organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives

Strong written and verbal communication, interpersonal and presentation skills to drive results

Establish solid working relationships to interface with other business units, third parties and other positions and circumstances within the organization

Demonstrates excellent customer service skills with the flexibility to respond to changes quickly

Maintain a professional demeanor and handle confidential information with discretion

Computer literate with proficiency in office applications, word processing, spreadsheets, graphics and statistical programs, and use of electronic quality and operational systems

ASQ Certification preferred

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.