Sr. Quality Specialist
This role supports Operations and Quality by ensuring compliance with regulatory requirements and driving process improvements. The associate partners closely with Quality to respond to quality events, improve processes, and maintain quality system standards.
Responsibilities
- Ensure compliance with regulatory requirements.
- Drive process improvements within the organization.
- Collaborate with the Quality team to respond to quality events effectively.
- Maintain and enhance quality system standards.
Requirements
- Quality assurance expertise.
- Experience with FDA regulations.
- Bachelor’s degree in Life Sciences or a technical field.
- Proficiency in document control and deviation management.
- Strong documentation and analytical skills.
Additional Qualifications
- Experience in the medical device industry is a plus.
- Familiarity with CGMP and CAPA processes.
- Ability to conduct audits.
Work Environment
The work schedule is Monday to Friday, first shift, and the position is on-site at a facility with approximately 50 employees in New Cumberland, PA.
Pay
The pay range for this position is $42.00 - $55.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
Eligibility requirements apply to some benefits and may depend on job classification and length of employment. If eligible, benefits for this temporary role may include:
- Medical, dental, and vision insurance
- Critical Illness, Accident, and Hospital coverage
- 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)