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Validation Manager

Company: ACE Partners
Location: Pomona
Posted on: September 16, 2022

Job Description:

*Validation Manager **Pomona, CA**$100,000 - $140,000**SCOPE OF POSITION*Corporate Validation and Technical Manager is well organized, detail oriented, self- - motivated, and team player. Corporate Validation and Technical Manager is responsible for ensuring all quality, compliance, and regulatory standards are met per company goals and expectations. Serve as a management representative of the company.*PRIMARY**RESPONSIBILITIES* - Schedule and maintain the Validation Master Plan validations and activities performed in compliance with cGMP regulations and guidance. - Responsible for creating and executing installation qualifications, operation qualifications, performance qualifications, and re-qualification protocols for manufacturing/laboratory equipment and steam/media fill sterilization process in compliance with current regulating bodies such as ISO/cGMP. - Prepare and manage multiple projects including document/protocol preparation, testing, report generation, and statistical data analysis. - Perform and document manufacturing/laboratory deviations, investigations, and CAPA in a timely manner. - Collaborate with internal departments and external customers to plan and meet project goals and deadlines. - Serve as a management representative of the company. - Assist with technical writing and any other activities assigned by the Director of Quality. -*REQUIRED**SKILLS, KNOWLEDGE, AND ABILITIES*--- Strong knowledge and experience of FDA regulations related to the manufacture of drugs and devices.--- Knowledge and understanding of the drug and device development process, quality systems, analytical testing, microbiological testing, stability, and equipment/ process validation.--- Demonstrate knowledge and experience in sterile (aseptic process) and non-sterile pharmaceutical manufacturing.--- Exhibit flexibility, open-mindedness, and adaptability to changing environment--- Excellent verbal and written communication with the ability for decision making skillsQUALIFICATIONS--- S.S. majoring in Microbiology/ Biochemistry/ Biology/ Life Science.--- 5 + years of quality assurance and regulatory experience in the pharmaceutical manufacturing environment preferably with working knowledge in aseptic manufacturing process.MINIMUM REQUIREMENTS--- Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.Job Type: Full-timeSalary: $100,000.00 - $135,000.00 per yearBenefits:* 401(k)* 401(k) matching* Dental insurance* Health insurance* Life insurance* Paid time off* Parental leave* Professional development assistance* Relocation assistance* Retirement plan* Vision insuranceSchedule:* Monday to FridaySupplemental pay types:* Bonus payExperience:* Validation: 5 years (Preferred)* Leadership: 3 years (Preferred)* Pharmaceutical/Biotech/Medical Device: 6 years (Preferred)Work Location: One location

Keywords: ACE Partners, Pomona , Validation Manager, Executive , Pomona, California

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