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Manager, Laboratory Compliance - Quality Assurance - Marietta, GA


Position Overview

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.

Duties and Responsibilities

  • Provide quality oversight for GMP laboratory activities.
  • Determine the acceptability of laboratory procedures and activities.
  • Review and approve laboratory documents including SOPs, specifications, change controls, investigations, CAPA, protocols, reports and other related documents.
  • Participate in improvement of laboratory processes to ensure quality and adherence to cGMPs
  • Conduct, review, and/or approve 21 CFR Part 11 assessments on new and existing computerized systems and GxP software/vendors; review and disposition periodic re-qualification assessments.
  • Support the development and management of quality metrics to optimize performance, productivity and effective resource planning.
  • Maintain awareness of current regulatory trends and impact on the compliance status of laboratory systems and processes.
  • May interface with regulatory agencies in support of inspections.
  • Perform other QA activities and responsibilities as assigned by management.
  • May be involved in laboratory issues and questions from third party suppliers.
  • Represent QA on laboratory project teams; leads and/or participates in special projects.
  • Oral Solid Dose experience required.

Core Competencies

  • Ability to work independently, interpret and assess technical documents, communicate and interact effectively across multiple organizational levels.
  • Working knowledge of laboratory compliance issues and best practices.
  • Ability to organize and adapt to organization priority changes and work effectively with minimal supervision with a sense of urgency.

Minimum Qualifications

  • BS in a science discipline
  • 5 years of work experience related to GMP production QC laboratory operations
  • Previous experience in managing a GMP laboratory is a plus

Preferred Experience

  • Experience with computerized management systems (e.g. ERP, LIMS, CDS, QMS, etc.)
  • Working knowledge of FDA’s current expectations related to laboratory activities

Physical Demands

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.

About Us

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.

 



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