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$70k–$78k/yr
Full-time
bachelor degree, postgraduate degree
Posted 22d ago
~40 hrs/week
Responsibilities
The Quality Assurance Specialist manages non-conformance investigations, CAPA tracking, and the product stability program. They are also responsible for conducting cGMP training, performing compliance audits, and acting as a liaison with chemical suppliers.
Requirements
Requires a Bachelor's degree in a scientific discipline with 3-5 years of QA experience, or a Master's degree with 1-3 years of experience, preferably in the OTC pharmaceutical industry. Candidates must be subject matter experts in cGMP requirements and proficient in statistical calculations and quality documentation.
Full job description
JOB SUMMARY
The Quality Assurance Specialist provides expertise to the Quality Department in one or more specialized areas. The Quality Assurance Specialist is responsible for performing investigations, completing Investigation Reports (IRs), tracking Corrective Action Preventive Action (CAPA), administering the product stability program, conducting current Good Manufacturing Practices (cGMP) training, maintaining a training record system, assisting with the Quality Management Software, acting as a liaison with chemical suppliers, and performing cGMP compliance audits.
ESSENTIAL JOB FUNCTIONS
Performs investigations of non-conformance including customer and consumer complaints and tracks resulting CAPA action plans.
Conducts cGMP training and maintains training records.
Administers the product stability program and designs compliant bracketing and matrix strategies for stability profiles.
Administers the cGMP compliance audit program.
Develops and maintains SOPs and forms governing areas of responsibility.
Acts as a liaison with raw material manufacturers and suppliers ensuring compliance with Blistex and regulatory requirements.
Assists Manager, Quality Assurance in administering the Quality Management Software.
Monitors regulatory and industry trends/actions and reports regularly to Quality management.
Develops and maintains performance measurements for areas of responsibility.
Master the ability to perform all associated Quality Assurance tasks to support and oversee Quality during Production, labeling and warehouse activities.
Solid working knowledge for performing investigation of non-conformance including consumer complaints investigation.
SME of cGMP requirements for an OTC drug manufacturing and able to apply the knowledge in daily tasks.
ADDITIONAL RESPONSIBILITIES
Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance and/or Director, Quality.
Supports the Winner’s Circle Process and Blistex Quality System.
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
Bachelor's degree in Chemistry, Biology, or related scientific discipline with 3-5 years of applicable Quality Assurance environment preferable in the pharmaceutical OTC industry.
Master's degree in Chemistry, Biology, or related scientific discipline with 1-3 years of applicable Quality Assurance environment preferable in the pharmaceutical OTC industry.
Proficient at effective communication skills for interactions with Quality colleagues, project managers, and colleagues from numerous functional areas.
Proficient at listening actively and readily assumes responsibility for actions.
Leads by example.
Proficient at managing tactical steps to push task forward.
Demonstrates high standards of ethics and compliance.
Creates culture of mutual trust and understanding.
Master the ability to perform all associated Quality Assurance tasks to support and oversee Quality during Production, labeling and warehouse activities.
Solid working knowledge for performing investigation of non-conformance including consumer complaints investigation.
SME of cGMP requirements for an OTC drug manufacturing and able to apply the knowledge in daily tasks.
Master the understanding of the organization QMS for retrieval requirements, retrieve essential records, following record keeping procedures.
Solid ability to detect errors in production documents reviews, deviations files, all quality documents support product release.
Mastered ability to perform and document thorough quality investigations.
Solid working ability to identify trends and/or patterns during non-conformances, deviation, stability, testing, and product review investigations.
Master and manage the Stability program. Master the ability to identify trends in the data and react according. Keep up with current Global ICH guidelines.
Master ability to handle multiple projects in logical sequence. Master ability to plan, organize and complete projects independently. Master keeping projects on target and on time with little to no delays.
Firm understanding of the calculations as required in Production and Quality Assurance SOPs and in performing basic statistical calculations related to % Difference, Average, Standard Deviation, % RSD. Solid understanding of how to review data for calculation errors and how to interpret data under supervision. Use data analysis and trends to assist in writing deviations, non-conformances, and investigational reports. Able to use statistical tool to analyze CAPAs effectiveness.
Mastered the requirements of the company nonconformance SOPs and perform the investigations. SME of the understanding of Quality and Compliance requirements.
Responsible for identifying deficiencies in Quality and Production documentation. Mastered working ability to complete sound, compliant, and thorough investigation and/or deviation.
Ability to propose effective CAPAs to investigation and/or deviation.
Effective interpersonal skills to interact with various levels of internal and external customers and suppliers.
Establishes priorities and works independently on a multitude of concurrent tasks with little supervision.
Detail-oriented and prepares comprehensive and accurate documentation.
Accepts other duties, as assigned.
Discreet with confidential information to which he/she has access.
Develops and maintains effective working relationships with internal and external customers and suppliers, functions as a team player, accepts constructive criticism from management, and complies with Company policies.
For millions of people around the world, our name is synonymous with lip moisturization, protection and relief. In short, simply the very best in lip care products anywhere.
But for the people at Blistex Inc., our name is more than a familiar brand. It is a standard that challenges each of us to provide our global consumers with the finest health care products.
At Blistex Inc., success begins with an excellent workforce. Then we channel our creative energies through an ongoing process that gives every employee - regardless of job title - the opportunity to contribute fully to the organization's success. Finally, we provide an environment that encourages involvement and respects the talents of the individual while fostering a team concept.
Blistex recognizes that continuing success in increasingly competitive global markets will require the constant pursuit of insight and excellence in all aspects of what we do. To help us meet our goal, we look to bring on-board talented individuals with a drive to succeed and a passion to satisfy the customer. Whether your expertise lies within sales, marketing, research & development, engineering, information technology, finance or manufacturing - Blistex has exciting opportunities.
For more information on career opportunities with Blistex, visit us on the web at http://careers.blistex.com.
Offices: 1800 Swift Dr, Oak Brook, Illinois 60523, US
Based on 3811 listings with disclosed salaries, most manufacturing jobs in Illinois pay between $68k–$155k per year. Individual offers vary with seniority, company size, and specialization.
How many Manufacturing jobs are open in Illinois right now?
There are currently 11,079 open manufacturing positions in Illinois listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Illinois?
Companies currently hiring include Caterpillar Inc., Allergan, RJW Logistics Group, Northrop Grumman, Kraft Heinz, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Illinois?
Yes — 1018 of the 11079 open manufacturing positions offer remote or hybrid work (246 remote, 772 hybrid).
How do I apply for Manufacturing jobs in Illinois?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.