QA Specialist (1st Shift)

Job Description

Job Description

Diversified Sourcing Solutions is actively seeking a highly detail-oriented and quality-driven QA Specialist / QA Technician to join a fast-paced pharmaceutical manufacturing environment supporting a growing 503B outsourcing facility. This is an excellent opportunity for experienced Quality professionals looking to make an immediate impact within a regulated GMP environment focused on compliance, documentation integrity, and operational excellence.

If you thrive in a highly regulated setting, excel at batch record review, and have experience working with quality systems and controlled documentation, we want to speak with you immediately.

Schedule & Pay

• 1st Shift: Monday–Friday | 8:30 AM – 5:00 PM
• Pay: $27.00 – $32.00/hour DOE
• Start Date: ASAP

Key Responsibilities

• Perform issuance and maintenance of Master Batch Records (MBRs)
• Conduct initial batch record and production documentation review for accuracy, completeness, and GMP compliance
• Support change control and document control activities as needed
• Review production logs and manufacturing records for proper entries and procedural compliance
• Provide QA floor support to operations personnel to ensure documentation is completed correctly and in real time
• Scan, file, organize, and maintain QA documentation within SharePoint and document management systems
• Manage the Document Control Room to ensure proper storage, retrieval, and organization of controlled documents
• Support annual archival and records management projects, including Iron Mountain documentation processes
• Maintain quality trending logs and support QA data entry activities
• Identify documentation discrepancies and escalate quality concerns appropriately
• Work within ISO Class 8 cleanroom environments while following gowning and safety procedures
• Support compliance initiatives within a regulated 503B pharmaceutical manufacturing environment

Qualifications & Experience

• Bachelor’s degree preferred, ideally in a scientific or related discipline
• Minimum 2 years of Quality Assurance experience in an FDA-regulated environment
  • Pharmaceutical, 503B, biotechnology, medical device, or related industries strongly preferred
• Strong understanding of:
  • GMP/cGMP regulations
  • FDA compliance requirements
  • Batch record review
  • Documentation control practices
  • Quality systems and compliance procedures
• Experience working with:
  • Microsoft Office Suite
  • Adobe
  • eQMS platforms
  • Document and inventory management systems
• Strong technical writing and controlled document review experience
• Excellent verbal and written communication skills
• Exceptional attention to detail and organizational ability
• Ability to multitask and prioritize effectively in a fast-paced, team-oriented environment
• Comfortable working independently while collaborating cross-functionally with Quality and Operations teams

Position Overview

The QA Specialist is responsible for supporting Quality Assurance operations with a primary focus on Master Batch Record (MBR) issuance, review, and GMP documentation compliance. This role plays a critical part in ensuring adherence to cGMP, FDA, and quality system requirements within a regulated pharmaceutical manufacturing environment.

This individual will partner closely with both Quality and Operations teams to maintain documentation accuracy, support compliance initiatives, and ensure production records are completed according to established procedures and regulatory standards.

Strong technical writing, organization, and attention to detail are essential for success in this role.

Diversified Sourcing Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.

Connecting Companies with Good Employees, and Employees with Good Companies!!

Company Description

Connecting Companies with Good Employees, and Employees with Good Companies!!