The QA Associate will be responsible for supporting Quality Assurance (QA) activities in compliance with FDA Regulations, cGMP, and Company policies, procedures and specifications at the company Distribution Center. Perform day to day technical activities in a Distribution Center environment supporting CMO/CPO for dietary supplements and drug product manufacturing, i.e. review and approval of documentation (batch manufacturing record and/or packaging, deviation, investigation, etc.), process changes, trouble shooting and improvements. The QA Associate position will need a robust understanding of applicable regulations, standards, and applicable company policies and procedures to ensure compliance. The QA Associate performs quality related activities of diverse scope, makes decisions and implements those actions in partnership with other departments at the site. This position will escalate compliance issues to QA Management. Duties and Responsibilities
Experience and Qualifications
- Perform documentation review (i.e. batch manufacturing and/or packaging records, Certificate of Compliance, Certificate of Analysis, etc.) with high attention to detail using working knowledge of quality concepts and internal procedures. Based on review, perform product release and disposition within company ERP system.
- Initiate, write, drive/lead deviations and investigations to ensure that all critical and major quality issues are thoroughly addressed and documented with appropriate associated CAPA.
- Participate in Change Control activities affecting procedures, processes and systems.
- Receive product quality complaints and perform activities to lead to closure and customer satisfaction.
- Write, review, and approve standard operating procedure (SOPs) and other applicable operation related GMP documents.
- Support and participate in trending of quality measures, CAPA plans, and annual reports.
- Escalate potential issues and concerns immediately to QA Management.
- Participate and assist in the GMP auditing program for internal and external audits including FDA, DEA, and FL-DBPR.
- Support the development, improvement and maintenance of Quality Systems including procedure development, process mapping in collaboration with other technical and business areas.
- Guide, develop and train others in areas of subject matter expertise.
- Follow and complete training according to the assigned training curricula. Execute and perform those activities that have been trained.
- Accomplish quality and organization goals by completing related activities as assigned, thoroughly and in a timely manner.
- Maintain a safe and healthy work environment by following written standards and procedures; complying with applicable regulatory requirements.
- Prompt and regular attendance. Other duties as assigned by senior management.
- Bachelor’s Degree in Science or Engineering or relevant scientific discipline from an accredited college or university.
- Minimum of three (3) years’ experience in pharmaceutical quality assurance or quality.
- Experience in a distribution center/warehouse environment preferred.
- Experience with DEA scheduled drugs is highly desirable.
- Strong knowledge of cGMPs (21 CFR 111, 211) and related FDA and International Conference on Harmonization (ICH) guidance documents.
- Good written and verbal communication and problem solving skills.
- Proficiency in MS Word, Excel, PowerPoint, and Outlook.
- Proficiency in English usage, spelling, grammar and punctuation.
- Effective planning and organizational skills.
- Requires flexibility and ability to multi-task.
Osmotica Pharmaceutical is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products using a proprietary osmotic technology platform. In February 2016, Osmotica Pharmaceutical combined with Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC to create a world-class, fully-integrated specialty pharmaceutical and generics company.
Vertical Pharmaceuticals, LLC was founded in 2003 with a mission to develop, market, and acquire products offering therapeutic benefits for patients and healthcare providers. Vertical Pharmaceuticals supplies branded prescription products, specializing in Neuroscience and Women’s Health with brands such as Lorzone®, Divigel®, and OB Complete®.
Trigen Laboratories, LLC is a generic pharmaceutical company offering unique products across an increasing array of categories. Trigen seeks to bring value-driven generic products to its customers, working vigorously with its partners to identify and develop products which face an assortment of challenges. Additionally, Trigen identifies unique marketing opportunities and is steadfast in its pursuit to deliver products to best serve these markets.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.
Product Quality Assurance