DescriptionYour Role:The role of the
Sr. Specialist, Quality Systems, is to provide technical review of Quality Management System discrepancy reports and CAPAs. In this role, you will participate in the generation and revision of controlled and project documents, perform assigned tasks and work to achieve company goals and department objectives and provide visible leadership to the organization that will instill operational best practices, a team-oriented work environment and productive results to the organization.
- Author, review, edit, and approve discrepancy reports including, but not limited to, reports for deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.
- Author, review, edit, and approve CAPA records; ensure CAPA records meet procedural and regulatory requirements.
- Author, review, edit, and approve controlled documents including, but not limited to, standard operating procedure (SOPs), forms, and BPRs.
- Participate in the generation and revision of controlled and project documents; author, review, edit, and approve controlled documents (including procedures, methods, and forms related to quality systems and to manufacture and testing of product) and project documents (including protocols and reports related to development, validation, and stability).
- Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams.
- Maintain a state of inspection readiness; participate in inspection preparation activities.
- Provide assistance to internal and external customers in support of departmental functions.
- Collaborate with Management to establish and meet targets and timelines.
- Independently manage competing priorities with limited instruction.
- Follow company policies and procedures.
- Perform other duties as assigned by management.
Minimum Qualifications:- B.A. or B.S. degree (preferably in a life sciences field)
- Minimum of 4-5 years of experience in the biopharmaceutical industry (preferably with biologics).
- Knowledge of cGMPs or equivalent regulations.
- Ability to interpret Quality standards for implementation.
- Skills to independently evaluate situations and propose potential solutions.
- Ability to interpret Quality standards for implementation.
- Excellent technical writing and editing skills.
- Progressive experience with deviation records.
- Experience using quality systems software (quality management systems and/or electronic document management systems)
Position Type/Expected Hours of Work:This role is a full-time onsite position. Days of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.
Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $42.19 to $56.05 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are: - You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
