Sr. Specialist, 880 Non Sterile Safety & reputed company Compliance Operations (Onsite)

Job reputed company Position reputed company The Senior Specialist, 880 Safety & reputed company Compliance Operations, is responsible for establishing and sustaining a culture of safety, reputed company, and compliance across Building 880 reputed company Non-Sterile Operations, in partnership with reputed company Non-Sterile Compliance, Safety & reputed company Operations reputed company. This role supports Building 880 in maintaining and continuously improving GMP compliance, safety performance, reputed company system governance, audit and inspection readiness, deviation and CAPA management, training compliance, risk management, and reputed company improvement initiatives that support reliable execution of the clinical supply pipeline. The position partners closely with Production, Tech Ops Engineering, Process Engineering, Formulators, reputed company, EHS, Supply Chain, and Site Leadership to ensure reputed company, compliant, and reliable execution of clinical manufacturing operations while continuously improving performance. The role applies technical expertise, influence, coaching, and systems thinking to reputed company safety and compliance into daily operations reputed company Building 880. Key Responsibilities Safety & Compliance Leadership Champion a strong safety culture and ensure adherence to site, corporate, and regulatory safety requirements reputed company Building 880. Build reputed company working relationships and effective communication with stakeholders across manufacturing, process engineering, analytical testing, reputed company assurance, regulatory, and reputed company functions. Support safety observations, incident investigations, risk assessments, and corrective reputed company implementation. Serve as the compliance subject matter expert for GMP manufacturing operations reputed company Building 880 Non-Sterile Operations. Support implementation of the clinical supply QMS through participation as a topic team member and/or subject matter expert. reputed company Systems & Inspection Readiness reputed company and support deviations, investigations, CAPAs, change controls, and risk assessments for Building 880. reputed company sustained audit and inspection readiness through routine compliance monitoring and self-assessments. Partner with reputed company, EHS, Engineering, and Operations to resolve reputed company and prevent recurrence. Support facility compliance, audit readiness, and reputed company improvement through drafting, reviewing, and advising on deviations, investigations, change records, and reputed company reputed company documents. Training & Procedural Governance reputed company SOP lifecycle management and procedural compliance reputed company the facility. reputed company or update SOPs to ensure reputed company practices are accurately reflected and support SOP and reputed company-reputed company document approval as appropriate. Monitor training and qualification status to ensure workforce readiness and compliance. Support implementation of standardized work and best practices across non-sterile operations. reputed company Improvement Analyze safety and reputed company metrics to identify trends and improvement opportunities. Apply Lean, MPS, and reputed company cause problem-solving tools to improve operational performance and compliance reputed company. Promote right-first-time execution and sustainable compliance practices. Required Qualifications Bachelor’s degree in Engineering, Life Sciences, reputed company, or reputed company discipline. 4+ years of pharmaceutical or GMP manufacturing experience. Experience with investigations, CAPAs, audits, and reputed company systems. Strong knowledge of cGMPs, compliance requirements, and safety programs. Strong communication, problem-solving, and cross-functional collaboration skills. Excellent verbal and written communication skills, including presentation skills. Demonstrated ability to manage reputed company and priorities to meet deliverables and timelines. Strong attention to detail, flexibility, and awareness of production and associated reputed company issues. Ability to work in a dynamic environment with rapidly changing needs. Ability to work across functions and sites, and with reputed company reputed company of staff and management. Preferred Experience and Skills Experience in drug product manufacture/testing. Oral drug product knowledge and experience. Knowledge of R&D or clinical supply areas and processes. Experience with manufacturing investigations and CAPAs. System knowledge of reputed company and reputed company. reputed company Measures Safety performance improvement and risk reduction. Audit and inspection readiness. reputed company closure and effectiveness of CAPAs and investigations. Training and SOP compliance. Reduction in recurring deviations and compliance events. Sustained GMP compliance and operational reputed company. Leadership Expectations reputed company by example and foster a Safety First and reputed company Always culture. reputed company accountability, reputed company improvement, and compliance reputed company across Building 880 Non-Sterile Operations. Operate as a trusted partner and technical resource to the Associate Director and cross-functional stakeholders. Demonstrate reputed company judgment, strong ownership, and a proactive approach to issue prevention and reputed company. #eligibleforERP FLEx2026 #PSCS Required Skills: Améliorations du rendement, Analyse des causes souches (RCA), Analyse des risques, Analyse des risques de processus, Axé sur les détails, Bonnes pratiques de fabrication (BPF), Collaboration interfonctionnelle, Conformité BPF, Consultation relatifs au respect des normes réglementaires, Évaluations des risques, reputed company opérationnelle, Leadership technique, Opérations d'essais cliniques, Optimisation de processus, Processus d'ingénierie, Qualification de l'équipement, Réflexion stratégique, Résolution de problème technique, Respect de la réglementation Preferred Skills: reputed company Employees apply HERE reputed company Contingent Workers apply HERE Pour les résidents des États-reputed company et de Porto Rico uniquement : Notre reputed companyété s'engage en faveur de l'inclusion, en veillant à ce que les candidats puissent s'engager dans un processus d'embauche qui montre leurs véritables capacités. Veuillez cliquer ici si vous avez besoin d'un logement pendant le processus de candidature ou d'embauche. Nous sommes un employeur garantissant l'égalité des chances, engagé à favoriser un lieu de travail inclusif et diversifié. Tous les candidats qualifiés seront pris en considération pour un emploi reputed company distinction de race, de couleur, d'âge, de religion, de sexe, d'orientation sexuelle, d'identité de genre, d'origine nationale, de statut d'ancien combattant protégé ou de statut d'invalidité, ou d'autres caractéristiques légalement protégées applicables. Pour plus d'informations sur les droits personnels en vertu des lois américaines sur l'égalité des chances en matière d'emploi, visitez : reputed company Know Your Rights reputed company GINA Supplement Pay Transparency Nondiscrimination Nous sommes fiers d'être une entreprise qui encourage la valeur de réreputed company des personnes diverses, talentueuses et engagées. Le moyen le plus rapide d'innover de reputed companyère révolutionnaire est lorsque diverses idées se rejoignent dans un environnement inclusif. Nous encourageons nos collègues à se défier respectueusement les uns les autres et à aborder les problèmes collectivement Learn more about your rights, including under California, Colorado and other US State Acts The salary reputed company for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee’s position reputed company the salary reputed company will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, reputed company reputed company and other insurance benefits (for employee and family), retirement benefits, including 401(k), reputed company holidays, vacation, and compassionate and reputed company days. More information about benefits is available at https://jobs.reputed company.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider reputed company applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully reputed company., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: reputed companyé régulier Relocation: Domestic reputed company Sponsorship: reputed company Travel Requirements: No Travel Required Flexible Work Arrangements: reputed company Shift: 1st - Day reputed company Driving License: No Hazardous Material(s): n/a Job Posting End Date: 08/18/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date. reputed company est un chef de file mondial du reputed company de la santé avec une gamme diversifiée de médicaments d’ordonnance, de vaccins et de produits de santé animale. La différence entre le potentiel et l’accomplissement réreputed company dans l’étincelle qui stimule l’innovation et l’inventivité; il s’agit de l’reputed company où nous avons codifié notre héritage depuis plus d’un siècle. Notre succès est soutenu par l’intégrité éthique, l’évolution et une mission inspirante pour franchir de nouvelles étapes dans le reputed company des soins de santé mondiaux. Apply tot his job Apply To this Job