Job description

Job Title: Senior Quality Specialist

Location: West Point, PA

Duration: 12 Months (Possibility to extend)

Qualifications:

Education Minimum Requirement: Bachelor’s degree or higher in a scientific or technical discipline

Required Experience and Skills**:

• Minimum of 7 years’ experience in the pharmaceutical industry with a thorough knowledge and broad experience of Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Must have hands-on experience working in IT - Quality Management Systems (SAP, Trackwise, etc.).
• Biological Drug Substance experience, including experience in Process and Analytical Tech Transfer
• Experience with biologic and/or vaccine Quality Assurance, Quality Control, and manufacturing processes.
• Must have strong interpersonal, communication, coaching, motivation, negotiation, multitasking, and persuasion skills to build strong relationships.

Preferred Experience and Skills:

• Excellent analytical and computer skills, including experience with Microsoft team
• The ability to navigate in a complex environment with the ability to make ambiguous situations clear to stakeholders (e.g., process mapping, PowerPoint).
• Strong collaboration, influencing skills along with Six Sigma / MPS experience. Ability to work independently and interact with all levels of the organization.
• Build and maintain strong relationships with external parties.

Note: Flexible work schedule. Looking for a senior quality professional with quality organization and experience is tech transfer, validation, protocols, Mater Batch records (MBR) and risk assessment.

Responsibilities:

• Review and/or approve technical documents including deviations, CAPAs and Change Controls.
• Manage quality tasks/responsibilities related to Change Controls (Process and Analytical) associated with the Tech Transfer.
• Reviewing Master and executed batch records for completeness and compliance to all associated source documents and regulatory filings and executing the batch disposition process
• Support GMP and PPQ readiness including review of source documents, Validation protocols and reports, Master Batch Records, Change Controls and Deviations.
• Participate in Quality Risk Management activities associated with the Tech Transfer project and External Entity.

Appreciate your response. Thank you!

Job Type: Contract

Pay: Up to $60.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Work Location: In person

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.