Senior Specialist, GxP Compliance and Documentation - Analytical Research & Development (Hybrid)

Job Description

Job Description

The Analytical Research & Development (AR&D) Stability Operations and Compliance department of our Company Research Laboratories Division is seeking applicants for a Senior Specialist position in the GxP compliance and documentation team to support the global AR&D organization. The position will be based at the West Point, Pennsylvania research facility. 

The Compliance Senior Specialist will work as part of the integrated Stability Operations and Compliance team and be pivotal in driving a culture of quality and operational excellence and enabling harmonization across the global AR&D network.  This role is responsible for management and oversight of Good Manufacturing Practices (GMP) documentation, training, and standard operating procedures (SOPs) for global AR&D in addition to supporting the harmonization of AR&D procedures. The role will also focus on managing audit and inspection activities for AR&D groups at the West Point site including ensuring inspection readiness, working with the labs prior to audits/inspections for preparation efforts, supporting lab staff during audits/inspections, and managing observation responses and CAPAs.  Experience supporting laboratory audits and inspections is a preferred skill.  The qualified candidate must possess effective leadership skills to enable the identification and implementation of innovative strategies for improvement to support the development pipeline across modalities – biologics, small molecules, and vaccines.

The successful candidate must be able to function independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.  We are looking for a team player with a passion for GMP compliance, strong organizational and project management skills, effective multi-tasking ability, and effective communication skills, both written and oral. Applicants must demonstrate a background of delivering innovative solutions to complex problems with a global mindset to drive cross-functional collaboration.

Education Minimum Requirements

• B.S. with 5+ years of post-degree relevant industry experience              

Required Experience and Skills

• Bachelor’s degree, or higher, in analytical chemistry or related field

• Minimum 5 years of experience in pharmaceutical or related industry supporting analytical laboratory testing or as quality assurance for laboratory areas.

• An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives.

• Demonstrated ability for taking initiative and innovative problem solving

• Desire and ability to learn new concepts outside of core expertise and training

• Excellent oral and written communication skills, demonstrated creativity, and effective interpersonal skills.

• Experience working within a GMP environment.

• Thorough understanding of GMP policies and procedures, knowledge of regulatory standards and proven experience working with Quality systems

• Ability to work independently and within a cross-functional team to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills

While not required, experience in one or more of the following areas is beneficial.

• Demonstrated commitment to diversity and inclusion.

• Experience leading a team for a common goal.

• Experience authoring SOPs for GMP analytical laboratories.

• Experience supporting GMP documentation and training within the pharmaceutical industry.

• Experience supporting internal audits and external inspections for analytical laboratories.

Tag: #AR&D

#eligibleforERP

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