QA Pharma Quality Specialist

Clariant Corporation
paid holidays, tuition reimbursement
United States, Texas, Clear Lake City
Sep 22, 2024
Job ID: 39027 \| Location: Clear Lake, Texas, USA Clariant is currently looking for a Quality Specialist for the global Quality Assurance (QA) Pharma team to support the Care Chemicals business unit in Clear Lake, TX. The QA Pharma Quality Specialist is responsible for ensuring that all pharmaceutical/healthcare products in the Clear Lake portfolio meet regulatory requirements and company quality standards. This role involves overseeing the quality assurance processes, conducting audits, reviewing documentation, supporting quality control processes, and collaborating with cross-functional teams to maintain compliance with International Pharmaceutical Excipients Council Good Manufacturing Practices (IPEC GMP) and other relevant regulations. This role is a full time, onsite opportunity. We offer a competitive salary, an annual bonus, PTO and more. If this role fits your background and interests, apply today - we look forward to hearing from you! Responsibilities * Define and support the implementation of IPEC requirements in production plants * Define and support the implementation of food/ dietary supplements requirements in production plants * Optimize Quality Management System to support the implementation of IPEC GMP requirements * Support Quality Control to ensure compliance to compendia and GMP * Advising internal departments and business development * Support Excipient GMP compliant equipment qualification and process validations * Ensure IPEC GMP compliant batch release process (i.e. Batch record review, deviation/OOS management, etc.) * Support compendial compliance in the Quality Control lab (e.g., method validation, specification, QM master data, etc.) * Support in supplier qualification for quality critical raw materials * Provide support to assess and close gaps in Quality Control lab * Maintain, update, and approve Standard Operating Procedures (SOPs) and other quality documentation * Identify opportunities for process improvements and lead initiatives to enhance product quality * Contribute to development of risk assessments * Communicate regularly with regulatory bodies and external partners like IPEC Americas regarding quality matters * Improve CSV/data integrity status * Assess change requests for IPEC GMP compliance Requirements * Bachelor's degree in a Chemistry, Quality Management, or a related field * Minimum 3-5 years of experience in pharmaceutical quality assurance * Previous experience in the manufacture and release of pharmaceutical excipients, preferred * Demonstrated experience with GMP, FDA, EMA regulations, and other relevant guidelines * Must be willing and able to work in a production and laboratory environment as needed * Ability to work under pressure and meet tight deadlines * Excellent analytical, problem-solving, and decision-making skills * Some travel, less than 5%, will be required to collaborate with QA colleagues and industry professionals Whats in it for you? Medical/Dental/Vision Insurances Paid Holidays PTO time with a carry-over benefit Tuition Reimbursement Wellness Program EAP Program Spending and Savings Accounts Life/AD&D Insurance Disability Insurance Pet Insurance Online discount Mall Auto/Home Insurance Identity Theft Protection Legal Services Plan Mahogany McClurkin Talent Acquisition Partner mahogany.mcclurkin@clariant.com Clariant is a Swiss-based global specialty chemicals company, which is concentrated and developed in three business units: Care Chemicals, Catalysts and Adsorbents & Additives. Our purpose as a company is reflected in our tagline "Greater chemistry - between people and planet", which considers the principles of customer, innovation and people orientation, as well as a focus on creating solutions to foster sustainability in different industries by offering high-value and high-performance chemical specialties. At Clariant, we believe that diversity, equity and inclusion are essential to our success. We strive to cultivate a workplace where all employees feel welcomed, respected, supported, and valued. Our diverse workforce allows us to tap into a wealth of perspectives, experiences, and capabilities that drive innovation. We are committed to ensuring equal opportunities for professional growth and advancement across all levels of the organization, based on objective criteria and regardless of gender, gender identity, race, ethnicity, religion, protected veteran status ,age, disability, sexual orientation or other aspects of diversity in accordance with the relevant governing laws. By bringing together talented individuals with diverse backgrounds and viewpoints, we gain the agility to meet the evolving needs of our global customers and communities. Join our team to help advance our mission of fostering a culture of belonging where everyone can thrive. Clariant Corporation is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, genetic information, sexual orientation, gender identity, disability, protected Veteran status, or any other protected class as established by law. Learn more about Clariant Follow us on Facebook, Twitter and LinkedIn Our commitment to people -download our Employment Standards Brochure