Quality System Specialist

BIOTECHNOLOGY COMPANY IN CAMARILLO, CA IS SEEKING A QUALITY SYSTEMS SPECIALIST TO COLLABORATE WITH THE TEAM TO DEVELOP, 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

• Initiate, execute and complete investigations associated with material/product specifications.

• 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.

• General understanding of global pharmaceutical product regulations with experience with ISO 9001 and/or 21 CFR Parts 210 and 211

• 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

Job Types: Full-time, Permanent

Pay: $70,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Camarillo, CA 93012: Reliably commute or planning to relocate before starting work (Required)

Shift availability:

• Day Shift (Required)

Work Location: In person

Salary : $70,000 - $0