PomonaRecruiter Since 2001
the smart solution for Pomona jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Pomona RSS job feeds