Quality Manager III

Immediate need for a talented Quality Manager III . This is a 12+ months contract opportunity with long-term potential and is located in Swiftwater, PA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-93870

Pay Range: $85 - $92/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• 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 of 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 of documents within assigned areas.
• 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.

Key Requirements and Technology Experience: 

• Key Skills; Processes and equipment for the manufacture of Drug Substance Vaccines
• Note from Manager: 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.
• Ability to work on strict deadlines.
• Background in life science. Ability to interface with cross-functional teams.
• Detail oriented. Strong working knowledge of Quality System Regulations.
• Experience leading CAPA (Corrective and Preventive Action) activities.
• Ability to handle multiple projects concurrently.
• Well-developed communication skills, both verbal and written. Years of Experience: 6 - 9 Years
• Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, Track Wise, SAP).
•  Experience leading CAPA (Corrective and Preventive Action) activities
• 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.

Our client is a leading Pharmaceuticals Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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