Manufacturing Quality Assurance Specialist II - 2nd Shift

Responsibilities

• On-shift support of manufacturing operations, providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing.
• Review of controlled Current Good Manufacturing Practices (cGMP) documentation and manufacturing records, including any deviations or Out-of-Specification (OOS) results.
• Participation in the release of raw materials, intermediates, and final products.
• Internal and external audits of facilities and products, observing critical operations and procedures, auditing documentation, recording activities, and keeping management informed on quality issues.
• Supports on-shift manufacturing operations and activities, including real-time auditing of production batch records, sampling, and Acceptable Quality Levels (AQLs), and line clearances.
• Supports the development and maintenance of Quality Systems as appropriate.
• Leads continuous improvement objectives to assure compliance with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations.
• Advises senior management on findings and recommendations related to internal and external auditing.
• Manages deviation, Out-of-Specification (OOS), Corrective and Preventive Action (CAPA), and Change Control Systems.
• Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards.
• Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
• Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
• Reviews and approves cGMP documentation, including procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
• Develops and maintains metrics and trending reports for Compliance-related activities.

Qualifications

• Bachelor's degree in a relevant field such as Pharmaceutical Sciences, Chemistry, Biology, or a related discipline.
• Minimum 5 years of experience in pharmaceutical manufacturing, quality control, or related fields.
• Experience with cGMP documentation and manufacturing records.
• Knowledge of FDA and DEA regulations.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.

Skills

• Quality Assurance/Quality Control (QA/QC)
• Manufacturing Operations
• Current Good Manufacturing Practices (cGMP)
• Pharmaceutical Development
• Root Cause Analysis
• Corrective and Preventive Actions (CAPA)
• Change Management
• Investigations
• Compliance Auditing

Benefits

• Competitive compensation package
• Flexible work schedule
• Professional development opportunities
• Health and wellness programs
• Employee recognition and rewards

Pay

• Salary range: $70,000 - $90,000 annually

Schedule

• Rotating shifts to cover manufacturing operations