Weekend Quality Control Manager — Lead in Pharma Ops

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 102,000 - 136,000; Full time

Benefits offered by this job

Medical, Dental, Vision

FSA/HSA

Life Insurance

AD&D

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier Spokane is seeking a Weekend Quality Control (QC) Manager to lead cross-functional oversight of Analytical, Microbiological, and Environmental Monitoring operations during weekend shifts, ensuring cGMP compliance and timely product testing.

You will collaborate with Production, QA, and QC teams, review data for accuracy, respond to EM excursions, and prepare for regulatory inspections.

Qualifications

• 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.
• Ability to work weekends and night shifts. Prolonged standing and sitting. Occasional work in aseptic areas (EM department only). Ability to respond to alarms or urgent issues on-site.
• Strong communication and conflict resolution skills; ability to work independently and make sound decisions under pressure; effective collaboration with cross-functional teams and leadership.
• There may be contact with allergenic source materials and extracts.

Responsibilities

• 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.
• Review and assess data generated for accuracy, completeness, and compliance.
• Monitor for potential trends or conditions that may adversely impact the quality of the sterile products and ensure corrective action measures are implemented when required/warranted.
• Respond to EM excursions, lab events, OOS/OOT results, and deviations in real time, initiating containment and corrective actions.
• 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 and ensure that all corrective actions are completed.
• Review and approve assigned SOPs, 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.

Skills

Strong communication

Team leadership

Decision making under pressure

Conflict resolution

Education

Bachelor's degree in Microbiology/ Biology/ Chemistry

Job description

Jubilant HollisterStier Spokane is seeking a Weekend Quality Control (QC) Manager to lead cross-functional oversight of Analytical, Microbiological, and Environmental Monitoring operations during weekend shifts, ensuring cGMP compliance and timely product testing.

You will collaborate with Production, QA, and QC teams, review data for accuracy, respond to EM excursions, and prepare for regulatory inspections.