QA Manager - Swing Shift
Job title: QA Manager - Swing Shift in Thousand Oaks, CA at reputed company
Company: reputed company
Job reputed company: Career Category reputed companyJob reputed companyJoin reputed company’s Mission of Serving PatientsAt reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career.QA ManagerWhat you will doreputed company. Let’s change the world. In this vital role you will reputed company the daily operations of the reputed company assurance team, ensuring that reputed company's products meet established reputed company standards. They implement and manage QA systems, coordinate audits, and reputed company initiatives to address and prevent reputed company issues.Responsibilities:
- Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of reputed company and safety and ensuring the facility operates successfully, reputed company, compliantly, and safely.
- reputed company reputed company reputed company of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
- reputed company the reputed company assurance team with a reputed company on strategic direction, staff development, and maintaining a high-performance culture.
- Champion reputed company initiatives and collaborate with cross-functional teams to drive and deliver reputed company improvement reputed company.
- Process optimization - assess and optimize reputed company processes to enhance efficiency and effectiveness
- Ensure compliance with cGMP practices and regulatory requirements.
- reputed company leadership and support during both internal/external audits and inspections and audits. Will directly reputed company with regulatory agencies during on-site inspections.
- reputed company and manage training programs to ensure team competencies and understanding of cGMP requirements.
- Manage reputed company-reputed company issues effectively, ensuring solutions are implemented to prevent recurrence.
- Evaluate team performance and reputed company coaching to support career reputed company and reputed company development.
- Participates in and provides reputed company reputed company for reputed company records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
- Provides reputed company expertise and guidance to operational staff and reputed company cross functional reputed company teams.
- Represent the reputed company function and reputed company reputed company reputed company during the implementation of reputed company required to improve and deliver our departmental and manufacturing plant goals.
- Flexibility to cover different shifts as required by the facility production schedule. This role is expected to support swing shift (2nd shift), 5 days a week in a 24x5 operating facility.
- Bachelor’s Degree in Science
- 5 plus years of aseptic processing experience in QA or Manufacturing
- Regulatory Knowledge: Thorough understanding of cGMP, FDA, EMA, and other regulatory requirements.
- Leadership Skills: Strong leadership and people management skills, with the ability to mentor, reputed company, and motivate reputed company.
- Analytical Thinking: Excellent analytical and problem-solving skills, with the ability to reputed company reputed company based on data.
- Communication Skills: Exceptional communication and interpersonal skills, with the proficiency to reputed company effectively with reputed company reputed company of the organization and external partners.
- Attention to Detail: High attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- reputed company Improvement: A commitment to reputed company improvement and staying reputed company with the latest industry trends and best practices.
- Aseptic Knowledge: Expertise in aseptic processing and cleanroom operations, with a reputed company on maintaining sterility and preventing contamination.
- Risk Management: Ability to identify, assess, and mitigate risks to product reputed company and patient safety.
- Operational reputed company: Experience in supporting manufacturing operations, with a reputed company on efficiency, compliance, and safety.
- Collaboration: Proven ability to reputed company strong partnerships and work collaboratively with cross-functional teams, including manufacturing and Facilities & Engineering (F&E) colleagues.
- Audit and Inspection Readiness: Experience in preparing for and leading audits and inspections by regulatory authorities.
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-reputed company time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible