**Summary of Essential Functions:** The Senior Quality Assurance Specialist will support manufacturing, warehouse, engineering, analytical services, supply chain, and other site departments as required. The ideal candidate should have prior GMP inspection experience within a pharmaceutical manufacturing facility or equivalent. The candidate must be detail-oriented, able to multitask and work in a fast-paced environment, possess strong oral and written communication skills, and have the ability to interact effectively with all levels of management and cross-functional teams. **Specific Duties, Activities, and Responsibilities:** + **Routine Auditing and Compliance** : Perform regular audits of the manufacturing facility to ensure compliance with cGMP, DEA, FDA, and local site procedures. + **QA Support for Manufacturing** : Provide QA support for clinical and commercial batches, ensuring GMP compliance in production activities. + **Line Clearances & Inspections** : Conduct line clearances, equipment releases, AQL inspections, and in-process checks as defined by quality procedures. + **QA Logbook Management** : Execute, review, approve, and maintain QA department logbooks, including but not limited to QA HOLD, Rejection, and PBR trackers. + **Audit Raw Materials and Facility Logs** : Conduct audits of raw materials, warehouse, and facility logs to ensure proper documentation and compliance. + **Review and Approval of Records** : Review and approve Cleaning Batch Records (CBR), Production Batch Records (PBR), and Master Batch Records (MBR). + **Audit Participation** : Participate in regulatory, customer, and internal audits to ensure compliance with industry standards and regulatory requirements. + **Quality Systems Management** : Assist with the quality review and closure of various quality system records, including deviations, complaints, change controls, and OOS/OOT investigations. + **SOP Creation and Revision** : Create, revise, and approve site Standard Operating Procedures (SOPs) to ensure compliance with current industry standards and regulatory requirements. + **Non-Conformance Investigation** : Act as a QA representative in non-conformance investigations, ensuring proper documentation and root cause analysis. + **Quality System Approval** : Support site quality review and approval of quality systems record closures, including deviations, change controls, and complaints. + **Document Review and Approval** : Review and approve critical documents from the analytical department, such as CoAs, stability reports, method validations, protocols, and micro reports. + **Retain Sample Inspections** : Perform annual retain sample inspections to ensure sample integrity and compliance with regulatory requirements. + **Batch Disposition Decisions** : Make final approval/rejection decisions on batch disposition, ensuring compliance with quality standards and regulatory requirements. + **Raw Material Approval** : Review, approve, and release raw materials for manufacturing processes, ensuring compliance with quality specifications. + **Cross-Departmental Communication** : Facilitate interdepartmental communication to obtain necessary information and resolve issues efficiently. + **Quality Event and Batch Investigations** : Assist with the investigation and resolution of quality events and batch-related issues. + **Shift Flexibility** : Willing to work flexible shifts and rotational weekend work to support manufacturing operations, including extended hours as required. **Position Requirements:** **Education and Experience:** + Minimum **Bachelor’s degree** or equivalent in a related field with **3+ years** of relevant experience in Quality Assurance, Compliance, or Manufacturing within the pharmaceutical industry. Thorough understanding of compliance, regulations, and inspection techniques, including cGMP. Demonstrated ability to evaluate facility records, processes, procedures, and practices to ensure conformance to industry regulations. **Knowledge/Skills:** + Strong knowledge of **FDA** , **cGMP** , and **DEA** regulations pertaining to pharmaceutical development and manufacturing. + **Mathematical** skills to analyze data and perform necessary calculations for quality assurance activities. + Familiarity with **SDS requirements** and the ability to understand safety procedures related to hazardous materials and chemicals. + Knowledge of document control procedures and their application within the **Quality Assurance** function. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.