Quality Assurance Operations Specialist (Night Shift)

Responsibilities Provide QA oversight to GMP operations on the assigned night shift; ensure GMP compliance and inspection readiness. Maintain a safe work environment and support Health, Safety, and Environmental corporate and site goals. Follow good documentation practices and site procedures. Lead, mentor, and coach operations and support personnel on quality matters. Ensure regular presence in operational areas to monitor GMP programs and quality systems. Assess and triage deviations within the local process team; support issue resolution and escalation to site-based process teams. Resolve or provide advice on product‑related issues with internal support groups and external partners. Participate in self‑led inspections and support regulatory inspections. Initiate, review, and approve quality documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls, engineering documents). Participate in continuous improvement projects to improve productivity. Approve commissioning, qualification, and validation documents for computer systems and equipment. Network with Global Parenteral Network sites to benchmark and replicate best practices. Basic Requirements Bachelor’s degree in science, engineering, or pharmaceutical‑related field. Minimum 3 years in the pharmaceutical industry with specific batch disposition experience. On‑site presence required. Work authorization required in the U.S. (company will not sponsor visas). Additional Skills/Preferences Demonstrated understanding of cGMP and experience in GMP production environments. Experience with C&Q and validation oversight, including automation and computer systems validation. Knowledge of US/EU/Japan and other pharmaceutical manufacturing regulations. Proficiency with applicable computer systems and Manufacturing Execution Systems. Experience with CSQA and electronic validation software (e.g., KNEAT). Strong communication and technical writing skills. Ability to perform root cause analysis/troubleshooting. ASQ certification. Schedule / Other Primary location: Kenosha County, WI. Work 12‑hour shifts (1800–0600) onsite on a rotating 2‑2‑3 (or similar) schedule; overtime/off‑shift support may be required; travel ~10%. Benefits Eligibility for a company‑sponsored 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits (e.g., healthcare/dependent day care FSA); life insurance/death benefits; certain time off/leave of absence; well‑being benefits (e.g., EAP, fitness, employee clubs/activities). Company bonus eligibility for full‑time equivalent employees. Work Authorization / Application Instruction If you require accommodation to submit a resume, complete the workplace accommodation request form: #J-18808-Ljbffr Scorpion Therapeutics