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
What s 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
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.
Not translated in selected language
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
Quality Control Manager
Maintaining the ASME quality control manual content & log for uncontrolled copies. This position is responsible for product quality and customer satisfaction of the complete MIRATECH product line, primarily in the Houston, TX facility. Assist with Quality questions on the shop floor. ...
QA/QC Manager - East Side
The QA/QC Manager is accountable for all Quality Department related activities for SeAH Steel USA, LLC. The Quality Assurance/Quality Control Manager will oversee the development, implementation and modification of advanced scientific and/or engineered methods, applications, programs, procedures, re...
Quality and Document Control Manager
Strong understanding of regulatory, legal, and quality requirements related to document control. Provide functional oversight and leadership to both domestic and international document controllers and records coordinators to ensure that processes are current and executed consistently. Supervises IDR...
Quality Assurance Service Specialist
The Quality Specialist is primarily responsible for management and oversite of subcontractors on behalf of Vallourec NA entities. The Quality Specialist is responsible for qualifying and auditing subcontractors to get them onto the approved supplier list for the entities in addition they will be inv...
Construction Quality Control Manager
Our dynamic and rapidly growing company is currently seeking a Quality Control Manager Professional to fill in as needed at job sites and/or short duration projects. Develop and Administer the Quality Control Plan for the project (following Army Corps Three Phases of Control). The primary responsibi...
QA Specialist (Hybrid)
The QA Specialist will perform testing activities relating to analysis, evaluation, testing, implementing, operating, or supporting existing and planned IT products and processes. The Quality Assurance Specialist will manage the quality of our products, and foster a “quality culture,” du...
Quality Assurance Specialist
Review quality issues with QAM and Center Manager periodically and as needed. Ensure that supplies and equipment are received, maintained, stored and documented to meet quality regulations. Encourage and participate in continuous quality improvement process. Direct observations of performance of rou...
QA QC Manager REMOTE ROLE
QA QC Manager - Data Center Construction Experience is Essential - Remote Role. We are currently seeking to add a QA QC Manager to the leading owners rep / engineering companies in the US. With over 15 years of data center construction experience under their belt already, the client is looking to bo...
Outpatient QA Specialist
MedX is hiring a Full-time Outpatient Quality Assurance Specialist. The Outpatient Quality Assurance Specialist will focus primarily on ensuring accurate and complete work based on departmental objectives while ensuring client satisfaction to include the following responsibilities:. Acceptable ...
Quality Assurance Specialist - Match Grant
Two years of experience working in quality assurance, audit, or related field. Capable of developing and implementing quality assurance standards as established in the program guidelines. Provide monthly reporting of MG case file quality and ensure effective communication with Refugee Services Progr...