Lexicon Pharmaceuticals is currently recruiting for an agile, resulted focused Quality Assurance Associate II to join our team in The Woodlands, Texas.
The Quality Assurance Associate II will be responsible for assisting in the management of Lexicon’s quality systems in a regulated pharmaceutical environment with regard to US laws, international regulations, and internal policies and procedures.
Key Responsibilities include but will not be limited to:
Assist in the review and processing of quality documents associated with clinical, manufacturing and technical support documentation. Author and/or review SOPs as needed
Provide hands-on QA support in the MBR and EBR review including batch release as needed. Assist in the QC of genealogy reports received from CMOs.
Assist in the management of Lexicon’s employee training program and serve as MasterControl administrator and as backup across all functional areas
Support CAPA program, deviation management, internal/external audit program, assignment tracking numbers, and in label and packaging control and specifications associated with components, drug substance and drug product
Generate and create quarterly quality metrics/indicators associated with quality systems.
Support all quality systems associated with GxP operations in collaboration with GMP and GCP directors to ensure compliance at all times.
Bachelor’s Degree required in biological sciences or chemistry
Six years of experience in GxP regulated environment with a minimum of four years of experience in quality assurance and at least two years of managing document control and training functions
Demonstrated expertise related to understanding the principles and application of quality and regulatory compliance related to GxP regulated activities and effective support of all regulatory authority inspections
Knowledge of US and international pharmaceutical regulations and ICH including the ability to interpret and apply GxP industry standards
Experience working in solid dosage forms
Experience in the use of MasterControl is a plus
Experience in performing internal/external audits a plus
Excellent verbal and written communication skills
Ability to communicate effectively between departments/disciplines in a matrix environment
Outstanding ability to produce technical documents for all levels of corporate structure and regulatory authorities
Must be exceptionally attentive to detail and organization.
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science, based on Nobel Prize-winning technology, to discover and develop precise medicines for patients with serious, chronic conditions.
Our world class research and commercialization teams are located in Basking Ridge, New Jersey and The Woodlands, Texas. Lexicon employees are inspired by the ...idea that their work can improve patients' lives and we know that our employees are important to the success of our mission. We are dedicated to making Lexicon a great place to work by providing employees with the benefits, services, and programs which will allow them to reach their full potential.
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Questions? Please contact our Customer Service Team 1-888-491-8833 Ext. 2238 (Extension Required)