Sr. Quality Specialist

This role supports Operations and Quality by ensuring compliance with regulatory requirements and driving continuous process improvements within a pharmaceutical or biotechnology environment. The Quality Assurance Specialist partners closely with the Quality team to respond to quality events, enhance operational processes, and maintain robust quality system standards in alignment with FDA regulations and cGMP requirements.

Responsibilities

• Support Operations and Quality functions by ensuring adherence to applicable regulatory requirements and internal quality standards.
• Partner closely with the Quality team to investigate, assess, and respond to quality events in a timely and compliant manner.
• Contribute to the maintenance and improvement of the quality management system, ensuring documentation and processes meet regulatory and company standards.
• Drive process improvement initiatives that enhance product quality, operational efficiency, and regulatory compliance.
• Manage and control quality documentation, including creation, revision, review, and archiving of controlled documents.
• Support CAPA (Corrective and Preventive Action) activities, including root cause analysis, implementation of corrective actions, and effectiveness checks.
• Participate in deviation management by documenting, tracking, and helping resolve deviations in accordance with established procedures.
• Assist in preparation for and participation in internal and external audits, ensuring records and processes are audit-ready.
• Apply cGMP principles in daily work and promote a culture of quality and compliance across the site.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into operational processes and continuous improvement efforts.

Requirements

• Quality assurance experience in a regulated pharmaceutical or biotechnology environment.
• Demonstrated knowledge of FDA regulations and their application to quality systems and operations.
• Understanding of cGMP requirements and ability to apply them in day-to-day activities.
• Experience with CAPA processes, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Hands-on experience with document control practices, including managing controlled documents and maintaining accurate records.
• Familiarity with audit processes, including preparation for and participation in internal or external audits.
• Experience in deviation management, including documentation, tracking, and resolution of deviations.
• Strong documentation skills with meticulous attention to detail and accuracy.
• Strong analytical skills with the ability to interpret data, identify trends, and propose improvements.
• Bachelor’s degree in Life Sciences or a technical field.

Skills

• Experience working with medical devices is a plus, in addition to experience in pharmaceutical or biotechnology settings.
• Ability to collaborate effectively with cross-functional teams, particularly Operations and Quality.
• Strong organizational skills with the ability to manage multiple tasks and priorities in a regulated environment.
• Clear written and verbal communication skills for documenting quality activities and interacting with stakeholders.
• Continuous improvement mindset with a focus on enhancing quality systems and operational processes.

Work Environment

This is an on-site, first-shift position working Monday through Friday at a facility with approximately 50 employees. The environment is a regulated pharmaceutical or biotechnology site that emphasizes compliance, collaboration, and a strong quality culture. Team members work closely across Operations and Quality, using established quality systems, documentation tools, and cGMP practices to support reliable and compliant operations.

Pay

The pay range for this position is $42.00 - $55.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a fully onsite, first-shift position in New Cumberland, PA, working Monday through Friday.