The Manager, Laboratory Compliance has the quality oversight over all site laboratory activities to ensure quality and regulatory requirements (21 CFR 210, 211, and Part 11) are achieved. This is accomplished through partnership with the Analytical Services, Validation Department, IT Department, and system/process owners to ensure laboratory compliance requirements are defined and followed.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). There are no lifting requirements. Periodic/infrequent travel to sister sites may be required. No Personal Protective equipment required, unless entering production areas.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
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 niche over the counter and prescription pharmaceutical preparations, specializing in women's health and pain management with brands such as Divigel®, OB Complete®, Lorzone®, & ConZip®.
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.