Manager, QC - Weekend

Job Description

The position of Weekend Quality Control (QC) Manager is responsible for providing cross-functional oversight and real-time decision-making across Analytical, Microbiological, and Environmental Monitoring (EM) operations during weekend shifts. This role ensures uninterrupted support of manufacturing and in-process testing activities, maintaining compliance with cGMPs and regulatory expectations.

Responsibilities

• Recommend product disposition and preventative and corrective actions to ensure compliance with cGMP's.
• Facilitate laboratory operation, ensuring support for production activities during weekend shifts and coordination with weekday shifts.
• Collaborate with Production, QA, and QC teams to align testing priorities and resolve issues.
• Provide oversight and guidance for analytical and microbiological testing, including EM sampling and trending.
• Maintain awareness of regulatory guidance and standards and ensure laboratory compliance with all applicable regulations.
• Respond to EM excursions, lab events, OOS/OOT results, and deviations in real time, initiating containment and corrective actions.
• Support timely documentation of investigations and escalation as warranted.
• Ensure readiness for regulatory inspections and customer audits through proper documentation and data integrity.
• Provide necessary summaries and reviews for regulatory and customer inspectors/auditors; provide responses to written observations made by the inspector/auditors and ensure that all corrective actions are completed.
• Review and approve assigned Standard Operating Procedures (SOP’s), Protocols, Acceptance Reports, and Specifications from the perspective of scientific soundness and compliance with applicable regulatory and/or procedural requirements.
• Provide guidance over method transfers, qualifications, verifications, and validations in accordance with industry standards and regulatory guidance.
• Provide training and mentorship to QC staff across disciplines.
• Maintain awareness of facility aseptic practices and provide input on contamination control strategies.

Qualifications

• Required: Bachelor Degree in Microbiology, Biology, Chemistry, or related hard science. Minimum 5 years related experience required. Pharmaceutical or FDA regulated industry experience required. In-depth understanding of cGMP’s, European regulatory requirements, and relevant USP chapters is required.
• Prolonged standing and sitting Occasional work in aseptic areas (EM department only)
• Ability to work weekends and night shifts.
• Strong communication and conflict resolution skills.
• Effective collaboration with cross-functional teams and leadership.
• Skilled in mentoring and guiding staff during off-hour.

Benefits

• Hiring Wage: $102,100 – $136,100 annually + 12% shift differential, with opportunities for growth, promotion, and annual raises.
• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program