Quality Compliance Specialist Regulated CAPA & Audits

Adecco Portugal

Salisbury (MD)

On-site

USD 36,000 - 55,000

Full time

8 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short-term disability
401K plan
Paid leave and holidays

Job summary

Adecco is hiring a Quality Compliance Specialist (Level I / Level II) for our Salisbury, MD site. You will oversee quality/compliance activities, review critical documents, and drive CAPA and continuous improvement.

This role collaborates with Regulatory Affairs, QA, and Production to meet regulatory expectations. Level I requires a BS in a scientific field with 2 years in an FDA-regulated environment; Level II adds greater experience and audit familiarity.

Qualifications

  • BS degree in a scientific field is preferred.
  • Minimum 2 years of related experience in an FDA-regulated industry.
  • Fundamental understanding of cGMP regulations and global standards.
  • Strong written and oral communication skills; ability to work independently.
  • Willingness to travel ~10% domestic, occasional international.

Responsibilities

  • Provide quality and compliance oversight for manufacturing and warehouse activities.
  • Review batch records, labeling, COA, reprocessing instructions, and deviations.
  • Facilitate CAPA plans and coordinate investigations of complaints.
  • Maintain and monitor compliance tracking systems and archives.
  • Assist in developing SOPs, forms, flow diagrams, and specifications.
  • Prepare site for FDA/USDA audits and support regulatory responses.

Skills

Strong communication
Attention to detail
Time management
Problem solving
MS Office proficiency

Education

BS degree in a scientific field
Certified Quality Auditor (CQA) preferred

Tools

MS Office Suite

Job description

Adecco is hiring a Quality Compliance Specialist (Level I / Level II) for our Salisbury, MD site. You will oversee quality/compliance activities, review critical documents, and drive CAPA and continuous improvement.

This role collaborates with Regulatory Affairs, QA, and Production to meet regulatory expectations. Level I requires a BS in a scientific field with 2 years in an FDA-regulated environment; Level II adds greater experience and audit familiarity.

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