Full 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 also include recommending product disposition and preventative and corrective actions to ensure compliance with cGMP's. Essential to this role is the responsibility to maintain awareness of regulatory guidance and standards and to ensure laboratory compliance with all applicable regulations.
• 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. Ensure that all applicable regulatory requirements are being met as prescribed within the procedures and practices of their respective QC department.
• 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 being manufactured and ensure that 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. 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.
• 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 Skilled in mentoring and guiding staff during off-hour.
• There may be contact with allergenic source materials and extracts.
Preferred
• Master's Degree in Microbiology, Biology or Chemistry
• 10+ years experience desired.
• Min. 3 years lead/supervisory experience required. Managerial experience desired.
• Weekend/night shift experience desired.
• Aseptic manufacturing experience desired.
• Quality Assurance experience desired
Location: Spokane, WA - On Site, Full-Time
Shift: Weekend Days | Friday-Sunday +E/O Thursday 6am-6pm
Compensation & Benefits That Start on Day One - Because Your Well Being Matters
Hiring Wage: $102,100 - $136,100 annually + 12% shift differential, with opportunities for growth, promotion, and annual raises.
At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:
• 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
Unlock Your Potential
If you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:
Careers - Jubilant HollisterStier