Senior Quality Assurance Engineer
Beacon Hill Staffing Group, LLC

Job Info

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Summary of Position

The Senior Quality Assurance Engineer is responsible for the Quality oversight for Validation, Engineering and Maintenance at the site. This position requires strong technical and quality skills. The position reports directly to the Senior Manager or Senior Director of Quality Assurance. Knowledge of pharmaceutical quality systems with proficiency in quality oversight of: Validation, Engineering, Maintenance, Manufacturing, QC, Regulatory, CAPA, Deviations, Out of Specification Investigations, and Annual Product Reviews.

Essential Functions:

• Take a lead role in the site/corporate development and maintenance of the facility's quality systems and procedures.
• Review and approve Change Control/Process Management Documents involving product or process changes.
• Key personnel for FDA or other regulatory agencies for on-site audits.
• Reviews and approves IOQs, requirement documents, SOPs, validation documents, and data integrity assessments.
• Assemble, analyze, and report QA system data to ensure regulatory compliance, identify trends, and identify areas of improvement.
• Conduct quality audits and develop and assess subsequent corrective action recommendation(s).
• Developing procedures, statistical evaluations, and remediation of systems.
• Ability to adapt quickly in a fast-paced dynamic environment.
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
• Ensure a safe and quality working environment through training, awareness, and compliance with safety guidelines and SOP's.
• Ensure the maintenance of the department, premises, and equipment.
• Additional areas of responsibility may include developing specifications and standard operating procedures, providing quality system training, and actively participating in Quality Review Board meetings.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Requirements:

• Bachelor of Science in Biology, Chemistry, Life Sciences, or related field required
• Five or more years of relevant Quality or Validation experience in a finished pharmaceutical manufacturing environment with a strong understanding of and exposure to applicable quality systems.
• Experience in supporting on-site inspections for regulatory agencies.
• Significant experience investigating Deviations and other variances.
• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes, and facility systems.
• Working knowledge of cGMP guidelines and their application in a controlled aseptic environment
• Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
• Must have experience with statistical tools. Proficient in the use of the Microsoft suite of products.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

Benefits Information:

Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.

We look forward to working with you!

Beacon Hill. Employing the Future™

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