Senior Specialist, Quality Assurance

Groupe Kardol; West Chester (Chester County); Presencial; USD 70.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

401(k) match

Healthcare coverage

Paid time off

Tuition reimbursement

Caregiving support

Descripción de la vacante

Groupe Kardol in the United States is seeking a QA professional to oversee GMP documentation, batch release, and product disposition across operations. This role collaborates with QA and site teams to ensure compliant processes and strong quality controls.

Responsibilities include reviewing change controls, deviations, investigations, and ensuring adherence to quality systems while mentoring junior QA staff. The position is full-time and located on-site in West Chester, PA.

Formación

• Prior experience in pharmaceutical industry, operations, or Quality Assurance.
• Knowledge of cGMPs, Quality Systems, and pharmaceutical supply chain environment.
• Excellent verbal and written communication skills.
• Strong motivation to learn and improve.
• Strong problem-solving skills.
• Ability to coach and mentor peers.

Responsabilidades

• Review and approve GMP documentation impacting operations and facilities.
• Disposition of incoming materials and finished product.
• Collaborate with QA professionals to ensure consistent application of quality systems.
• Execute QA processes: batch record review, product disposition, and issue resolution.
• Interface with site groups on projects to ensure GMP compliance.
• Lead process ownership and drive quality improvements across the site.
• Provide QA coaching to junior staff and other employees.

Conocimientos

Quality systems

Communication

Problem solving

Mentoring

Educación

Bachelor’s or Master’s in QA/regulatory affairs

Descripción del empleo

Position Summary

This position is responsible for all QA activities that directly support execution of the process both within the Operations Teams and in assigned areas outside of Operations. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Position Responsibilities

• Maintain a high level of understanding of relevant production processes and quality systems

• Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:

  • Change Requests

  • Batch Records and associated documentation

  • Product and Component Release transactions in SAP

  • Quality Investigations (Deviations, Product Complaints)

  • Validation Plans, Protocols and Reports

  • Standard Operating Procedures

• Accountable for disposition (release or rejection) of incoming materials and finished packaged product

• Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems

• Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives

• Interface with applicable site support groups on projects (capital and non-capital) that impact the operations/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects

• Collaborate with and influence other Operations/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices

• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders

• Collaborate in data analysis and report creation on quality metrics and key performance indicators

• Strong collaboration between other areas to ensure consistent application of quality systems/processes across the site

• Ability to work independently with minimal guidance from management

• Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration

• Demonstrate leadership capabilities

• Train and mentor junior members of the QA organization and provide QA coaching to other non-QA employees within the area supported

• Strong performance history of consistently meeting or exceeding expectations

• Hold other accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organization

• Demonstrate a strong understanding of the technology area to which the individual is aligned

• Act as an execution lead/process owner for one or more processes

Minimum Requirements

• Prior experience in either the pharmaceutical industry, an operations environment, or Quality Assurance

• Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment

• Excellent oral and written communication skills

• Strong ability and motivation to learn

• Strong problem-solving skills

• Ability to coach and mentor peers

Preferred Background

• Bachelor’s degree or master’s degree in quality assurance /regulatory affairs

• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement

• Multi-site / multi-functional experience

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Our target base pay hiring range for this position is $70,000.00 - $115,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge.