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Job Requirements of Quality Manager III:
-
Employment Type:
Contractor
-
Location:
Swiftwater, PA (Onsite)
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Quality Manager III
Careers Integrated Resources Inc
Swiftwater, PA (Onsite)
Contractor
Title: Quality Manager III
Duration: 12 Months+ Possible Extension
Location: Swiftwater, PA
Manager Notes:
Duration: 12 Months+ Possible Extension
Location: Swiftwater, PA
Manager Notes:
- Bachelor's Degree/Undergraduate Degree in engineering or technical discipline.
- Master Degree preferred.
- Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment - vaccines a plus.
- Strong working knowledge of Quality System Regulations.
- Experience leading CAPA (Corrective and Preventive Action) activities.
- Years of Experience: 6 - 9 Years
- This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance Vaccine manufacturing.
- We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
- The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance Vaccines and will review and approve validation related studies for assigned areas.
- These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
- This position has signatory responsibilities for validation/qualification documents within assigned areas.
- Candidates should have some knowledge in biotech manufacturing processes (i.e. viral antigen production).
- Excellent communication skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Client such as Manufacturing Technology, Engineering and Regulatory Affairs.
- Good interpersonal and influencing skills are important for a candidate’s success in this role.
- Bachelor’s degree in Engineering, Science, or related field with 5+ years' experience preferably in a cGMP environment.
- Strong knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing.
- Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, TrackWise, SAP).
- Ability to effectively communicate technical information to diverse stakeholders, including technical and non-technical audiences.
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