Quality Systems Specialist (Pharmaceutical Validation)

Ledgent Technology · Slaton, TX

ContractScientific ResearchPosted New
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Quality Systems Specialist (Pharmaceutical Validation & Compliance) Roth Staffing is looking for a Quality Systems Specialist with cGMP, FDA regulations, validation protocols, CAPA, RCA, FMEA, SOPs. This is a 12 months temp-contract role with an hourly pay rate of $32.00 to $35.00. Job Description: • Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes. • Conducts quality control for statistical analyses of testing results and process anomalies. • Ensures that corrective measures meet acceptable reliability standards. • Verifies calibration, maintenance and repair of instruments as applicable to support the Quality Systems validation program. • May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements. Responsibilities: • Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards. • Under direct supervision, assists in preparation, execution, data collection and reporting of validation studies to ensure the user needs and specifications are consistently met. • Prepares validation protocols and test equipment; evaluates validation test data. • Prepares reports on completed studies that summarize test results and their conformance to defined acceptance criteria. • Assists in developing programs and maintaining standard operating procedures (SOPs) validations. • May provide support related to management of procedural documents. • Communicates cross functionally regarding needs and status of assigned study activities and project deliverables. • Perform other job-related duties as assigned. Requirements: • Bachelor's Degree in Sciences or Engineering or equivalent combination of education, training and relevant work experience required. • ASQ Certification preferred. • 0-3 years' related quality/validation experience in pharmaceutical manufacturing/a highly regulated industry. • In-depth working knowledge of cGMP principles and applications. • Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations. • Participating in FMEA or RCA/CAPA development teams. • Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations. • Excellent negotiating, critical reasoning, decision-making, and problem solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects. • Strong project management and organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives. • Strong written and verbal communication, interpersonal and presentation skills to drive results. • Establish solid working relationships to interface with other business units, third parties and other positions and circumstances within the organization. • Demonstrates excellent customer service skills with the flexibility to respond to changes quickly. • Maintain a professional demeanor and handle confidential information with discretion. • Computer literate with proficiency in office applications, word processing, spreadsheets, graphics and statistical programs, and use of electronic quality and operational systems. • Understands complex problems to collaborate and explore alternative solutions. • Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit. • Attention to detail and ability to follow written and verbal directions in exact detail required. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.

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Full-timeTrucking
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Military Service Coordinator

US Government Jobs · Slaton, TX

Military Services Coordinator The Military Services Coordinator (MSC) in the Veterans Benefits Administration (VBA). The MSC performs liaison activities and conducts regular visits to out-based locations to assist active duty personnel in filing for future VA benefits. MSCs provide benefits dissemination briefings and claims intake to transitioning active duty, reservists and guard members as well as to Veterans throughout the community during Outreach programs and events.

Defense/Security Clearance
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Job Posting We work with many large corporations such as Boeing, AT&T, Exxon Mobil, Nabisco, etc., almost every company across every industry. Our primary function within these entities are to service their staff and ensure that they understand their benefits and what is available to them. Union members request our benefits packages because standard work benefits are often eliminated or reduced upon leaving or retirement. We provide unions with permanent benefits to give them the protection they need throughout their lives. We are the premier workplaces in North America, consistently being voted one of the best places to work, with Best Workplace awards in 2017, 2018 and 2019. We also have been named the 24th Happiest Places to Work by Forbes Magazine. Job Duties · Inbound and outbound calling · Scheduling appointments with clients who request our benefits · Presenting and explaining insurance products and benefits packages over Zoom video call · Completing applications for insurance products · Report daily numbers · Attend optional training classes · Completing tasks that an underwriter requires to get the client approved for the coverage What We Offer · Long-term career progression · Flexible work hours · Remote work from home option · Provide full training · Residual Income · Paid Weekly · Benefits (After 3 Months) All-expenses-paid yearly office trips to exciting and exotic locations (2016 Puerto Rico, 2017 Cancun, 2018 Disney, 2019 Vegas, 2020 Bar Mar Bahamas) Minimum Qualifications · Strong communication skills · Time management skills · 18+ years of age · High school diploma (higher education preferred but not required) · Customer service and/or retail experience preferred but not required In the interest of community wellness, our company has adjusted our business operations. As such, all interviews will be conducted via Video Conferencing.

NewWeekly payRemoteCustomer Service/Call Center
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Sr. Associate - Customer Care - Non - Voice Ready to turn bold ideas into real-world impact? At Genpact, we don't just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we're at the forefront of it. Genpact's AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies' most complex challenges. If you thrive in a fast-moving, innovation-driven environment, love building and deploying cutting-edge AI solutions, and want to push the boundaries of what's possible, this is your moment. Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world's leading enterprises. Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook. Job Description Responsibilities: • Process customer and account-related transactions accurately and efficiently in accordance with established procedures and service level agreements. • Review, research, and validate requests received from customers, financial institutions, internal departments, and other stakeholders. • Perform account maintenance activities, data verification, record updates, transaction reviews, and case processing tasks. • Analyze account information and supporting documentation to ensure completeness, accuracy, and compliance with business requirements. • Identify exceptions, discrepancies, or potential issues and escalate them to the appropriate teams when necessary. • Maintain accurate records and documentation of all actions taken within designated systems. • Meet productivity, quality, accuracy, compliance, and turnaround time targets. • Utilize multiple systems and applications to complete assigned tasks and resolve operational inquiries. • Support operational projects, process improvement initiatives, testing activities, and additional assignments as required. • Ensure compliance with company policies, client requirements, regulatory guidelines, and data privacy standards. Collaborate effectively with internal teams and business partners to resolve operational issues and improve customer outcomes Qualifications Bachelors - Business Administration, Bachelors - Communication, Bachelors - Hospitality Management, Bachelors - Information Technology, Bachelors - Marketing Certifications Certified Data Processor (CDP) - LinkedIn LearningLinkedIn Learning, ITIL Foundation - AxelosAxelos, Professional Customer Service - SMG/KRC Poland Human ResourcesSMG/KRC Poland Human Resources, Supply Chain Design Certification - LinkedIn LearningLinkedIn Learning Required Skills Account Maintenance, Banking Capital Markets, Claims Resolution, Customer Care, Customer Experience (CX), Customer Journey Mapping, Online Customer Support Language English (Required), English (Required) Language Proficiency - Upper Intermediate - B2 Additional Job Location - Job Type Regular Master Skill List - Customer Care - Non - Voice Remote Type - Remote Work Shift - Rotating (United States of America) The approximate annual base compensation range for this position is: 31,200 to 39,000 USD "Los Angeles, California based candidates are not eligible for this role. Richardson area candidates are eligible for this role only." The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors which include but are not limited to the applicant's experience, knowledge, skills, and abilities; geographic location; and internal equity. Why join Genpact? • Lead AI-powered transformation - Drive innovation and solve real-world business challenges that matter • Make an impact - Help global enterprises solve business challenges that matter • Accelerate your career - Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead • Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day • Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up. Let's build tomorrow together. Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation. Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

RemoteCustomer Service/Call Center
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