Quality Assurance Coordinator

Pride Health is seeking a
Quality Assurance Coordinator
for a life-sciences and diagnostics company providing services to the pharmaceutical and biotechnology industries.

Job Title: Quality Assurance Coordinator

Location: San Diego, CA 92121(On-Site)

Job Type: Contract

Length: 6-Months

Hours: 40 hours/week

Pay Rate: $ $35.10 per hour

Overview:

The Quality Assurance Coordinator will be a multi-faceted and integral part of the Quality Assurance team and will perform and administer Quality Assurance (QA) activities at Company, in accordance with Vision, Mission, Quality Policy and Quality Objectives for implementation, maintenance and improvement of Company's Quality Management System (QMS) and support the upcoming ERP system deployment.

Responsibilities:

• Processing document control requests as well as assisting with the ongoing ERP project as needed, while supporting document control duties and training processes within current eQMS system (Smartsolve) as needed.
• Working with one or more of the following quality system processes: document control and training.
• Interacting with other QA departments and processes: change management, nonconformance, complaint management, CAPA management, supplier quality management, internal audits, post-market surveillance and vigilance management, risk management, QA product release and QA design control responsibilities.
• Ensuring quality systems procedures are followed and records are compliant in their applicable areas of responsibility.
• Acts in a support capacity for critical QMS processes such as, non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing, supplier Management and validation.
• Reviews quality records for all related areas of responsibility.
• Demonstrates the ability to work with limited direction and can prioritize projects independently
• Responsible for personal daily task management, training plans and performance management.
• Assist with generating, reviews and maintains QMS documents.
• Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
• Assists with data preparation for Quality Management Reviews.
• Provides administrative support for external audits (regulatory or customer) and Internal Audits.
• Participates in the use of the eQMS system and expanded applications as appropriate.
• This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
• Assist with monthly and management review data and metrics for areas of responsibility
• Other projects or responsibilities as may be required.

Requirements:

• BA in a scientific discipline or equivalent work experience.
• 1-year work experience in quality assurance.
• Experience with GMP or similar regulated products. GMP/GLP proficiency.
• Work experience and knowledge of standards and regulations such as MDSAP, ISO 13485 and country and region-specific regulations (i.e. FDA 21 CFR 820, EU IVDD).
• Possess strong organization skills and attention to detail and accuracy and must be self-motivated, able to multi-task, and work effectively in a fast-paced environment; Good communication and interpersonal skills are essential in interactions with employees and others.
• Must be a fast learner with the ability to quickly analyze and solve problems.
• Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat (PDF)

Benefits that Pride Health offers:

Pride Health offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

Apply Today If you are interested in the position, please email your resume to rob.- for immediate consideration.