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BIOTECHNOLOGY COMPANY IN MARINA DEL REY, CA IS SEEKING AÂ QUALITY SYSTEM SPECIALISTÂ TO COLLABORATE WITH THE TEAM TO IMPLEMENT, AND MAINTAIN AND QUALITY MANAGEMENT SYSTEM FOR THE QUALITY TEAM! APPLY NOW!!
Description:
The Quality Assurance Specialist will collaborate with stakeholders to develop, implement, and maintain the Quality Management System and its platform. The QA Specialist I will execute risk assessments, develop testing methods and various quality assurance requirements. In addition, this position will provide regulatory and technical support for programs that oversee product specifications/requirements. The role will be responsible for the maintenance and implementation of corrective actions, validations, and technical documents.
Primary Responsibilities
• Expertise in the batch record review & release process
• Evaluate material/ product non-conformances to identify and assess root cause.
• Interface with impacted departments to identify and evaluate risk associated with product impact. • Provide support for all aspects of testing related to material specifications.
• Lead groups to ensure investigations and resolutions related to quality and product are completed.
• Effectively communicate, lead and support inspectors and production personnel as initial technical support contact.
• Participate in meetings/projects as required (safety, problem solving, team meetings).
• Participate in process improvement teams and/or completes relative documentation when required.
• Support quality manager in suggesting or communicating ideas for continuous improvement to maximize product quality and minimize costs. • Prepare and submit reports to the quality manager or supervisor.
• Support compliance with established practices, polices, to meet customer/contractual obligations and in compliance with regulatory codes and standards. • Comply with all safety requirements ensuring work areas meet standards.
• Responsible for facilitation of document control and training programs.
• Lead the management of risk assessments that pertain to or impact material and/or regulatory requirements.
• Minimum of 2 - 4 years’ experience with technical documentation for quality activities, such as corrective actions quality audits, and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.
• Solid organizational and planning skills.
• Be self-motivated, attentive to details and able to prioritize and meet deadlines.
• Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
• Must be able to work effectively and lead others efficiently in a team environment.
• Basic statistical mathematical and computer skills including the ability to trend data.
• Basic project management skills
• Independently understand, follow, and implement instructions.
Education/Training:
- Bachelor’s degree in a technical or scientific skill desired,
- 2-4 years of experience in quality assurance functions, including Root Cause Analysis, Corrective Actions, Effectiveness Checks/Verifications.
Skills:
quality assurance, root cause analysis, investigations, GMP, documentation, quality, attention to detail, document control, revision, materials specification, iso 9001, drug manufacturing, regulatory audit, regulatory, change controls, deviation management, TrackWise, veva vault, master control, qt9, internal audit, customer audit
Top Skills Details:
quality assurance, root cause analysis, investigations
Additional Skills & Qualifications:
needs to have experience owning and leading root cause analysis and investigations
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
