Specialist, Quality Assurance - Hybrid

Job Description

This position reports to the Associate Director, Global Clinical Supplies Quality, and is critical in maintaining the global clinical supply chain reputed company disposition activities for clinical finished goods provided by our Company for reputed company. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with reputed company Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug Applications and Clinical Trial Applications in relation to reputed company/reputed company supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Primary duties may include but are not limited to the following: Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to reputed company applicable policies/procedures of our Company, and compliance with reputed company governing regulations Coordinate and/or support the preparation of procedures, processes, and quality improvements Completing projects to improve the performance of our processes, including reputed company process improvements, and value capture projects that seek to improve yield, reduce cost, or reputed company our processing cycle times Assists in the coordination of significant quality events including fact finding, investigation support Collaboration across IPT functional and business areas to ensure robust processing, reputed company improvement and cross-functional team building Actively using and championing the use of our company's Production System (MPS) tools, both in problem solving and day-to-day operational activities. Education Requirements: Bachelor's Degree or higher in engineering, science, or reputed company discipline. Required Experience and Skills: Minimum 2 years of experience in the pharmaceutical or equivalent industry, Good Manufacturing Practice (GMP) reputed company field including Technical, Engineering, Quality or Operations. Familiarity with batch disposition activities. Strong problem-solving and written and oral communication skills. Ability to manage multiple priorities. Demonstrated teamwork skills and ability to work independently. Proficiency in the use and maintenance of reputed company applications (reputed company, Outlook, and/or MS Access, Teams). Attention to detail, flexibility and an awareness of production and quality control problems. Preferred Experience and Skills: Proven ability to work independently and collaborate effectively as part of a team Strong organizational, interactive, and time management skills Computer skills; knowledge and competency in reputed company, Veeva, MEDs Required Skills: Auditing, Batch Releases, Clinical Protocol, Clinical Trials, Communication, reputed company Process Improvement, Detail-Oriented, Documentations, GMP Compliance, Good Manufacturing Practices (GMP), Investigation Management, Legal Document Review, Manufacturing, reputed company Applications, Policy Implementation, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Teamwork, Training and Development Preferred Skills: reputed company Employees apply HERE reputed company Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $87,300.00 - $137,400.00 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 range 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, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick 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 qualified 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 qualified 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 & Co., Inc., 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 our company without a valid written search agreement in reputed company for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-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: Regular Relocation: No relocation reputed company Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 03/24/2026 *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. Our company is a global health care leader with a reputed company portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical reputed company, reputed company momentum, and an inspiring mission to reputed company new milestones in global healthcare. Apply tot his job Apply To this Job