Quality Specialist - III at West Point, PA 19486

Duration: 12 Months contract

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.

Comments/Special Instructions

Sr. CSP Vidushi Sharma.

• Industry experience: Pharma/biotech is must. Medical device not so much!
• Preference is previous Merck experience
• Senior person who can get the ball running
• Looking for quality organization and experience is tech transfer, validation, protocols, MBR and risk assessment

Job Type: Contract

Pay: $45.00 - $60.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• West Point, PA 19486: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: In person

Speak with the employer
+91 609-681-2430

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