QA Manager - Swing Shift
Job title: QA Manager - Swing Shift in Thousand Oaks, CA at reputed company
Company: reputed company
Job description: Career Category QualityJob DescriptionJoin 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 focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, 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 transform 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 quality assurance team, ensuring that the company's products meet established quality standards. They implement and manage QA systems, coordinate audits, and reputed company initiatives to address and prevent quality issues.Responsibilities:
- Partner with our colleagues in manufacturing, supply chain, facilities and engineering and automation to maintain our strong culture of quality and safety and ensuring the facility operates successfully, reputed company, compliantly, and safely.
- Provide quality reputed company of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
- reputed company the quality assurance team with a focus on strategic direction, staff development, and maintaining a high-performance culture.
- Champion quality initiatives and collaborate with cross-functional teams to drive and deliver reputed company improvement projects.
- Process optimization - assess and optimize quality processes to enhance efficiency and effectiveness
- Ensure compliance with cGMP practices and regulatory requirements.
- Provide leadership and support during both internal/external audits and inspections and audits. Will directly interact with regulatory agencies during on-site inspections.
- reputed company and manage training programs to ensure team competencies and understanding of cGMP requirements.
- Manage quality-reputed company issues effectively, ensuring solutions are implemented to prevent recurrence.
- Evaluate team performance and provide coaching to support career growth and professional development.
- Participates in and provides quality reputed company for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
- Provides quality expertise and guidance to operational staff and reputed company cross functional reputed company teams.
- Represent the Quality function and provide quality reputed company during the implementation of projects 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 a team.
- Analytical Thinking: Excellent analytical and problem-solving skills, with the ability to reputed company sound decisions based on data.
- Communication Skills: Exceptional communication and interpersonal skills, with the proficiency to interact effectively with reputed company levels 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 focus on maintaining sterility and preventing contamination.
- Risk Management: Ability to identify, assess, and mitigate risks to product quality and patient safety.
- Operational Excellence: Experience in supporting manufacturing operations, with a focus 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 vision 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-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible