Location: Buena, NJ
To provide a safe and healthy work environment for all of our employees and contractors, Teligent has mandated that all employees be fully vaccinated for COVID-19. This means that all new hires will be required to be fully vaccinated prior to their start date. We are taking this proactive step as our community continues to be negatively impacted by the pandemic and the surging Delta variant. Should you require a religious or medical accommodation, please inquire about necessary steps to secure such accommodations.
The Quality Assurance Stability Associate demonstrates clear understanding of current Good Manufacturing Practices and effectively manages all aspects of the stability program, including monitoring stability chambers, preparing stability protocols, maintaining inventories, distributing samples and logging in stability studies using applicable Laboratory Information Management System, as well as additional departmental duties as described below.
- Execute the day-to-day operations of the stability program for drug product, including stability sample set-down, labeling and pull requirements, ensuring a timely, effective, and compliant operation to meet regulatory requirements.
- Prepare Standard Operating Procedures (SOP’s), assists in preparing new stability protocols and revised documents as needed.
- Initiates, prepares, and revises new protocols, SOP’s, and other technical documents.
- Effectively interacts with supporting departments to address stability issues.
- Log in samples into LIMS and coordinates distribution to appropriate laboratories for testing and assumes responsibility to assist with stability sample issues.
- Performs investigations related to stability storage conditions being of out of specifications.
- Conducts review and approval of process validation stability protocols and stability studies in LIMS.
- Communicates inventory needs with supporting departments as needed.
- Determines disposal schedule for retained samples inside the chambers after completion of all stability studies.
- Liaise with the department members as needed to accomplish tasks in a timely manner.
- Ensure that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
- Report observations and key quality findings of ongoing stability studies to Supervisor.
- Adhere to safety and housekeeping requirements.
- Assume other activities and responsibilities from time to time as needed/directed.
- 3-5 years of relevant experience or equivalent in a cGMP/regulated environment
- Bachelor’s degree in science or health related major or equivalent experience.
- Good communications skills and be experienced in Acrobat Reader and Microsoft programs: Word, Excel, Access.
- Excellent multi-tasking and organizational skills.
- Demonstrated ability to work on multiple projects and meet timelines and detail oriented.
- Collaborative working style, demonstrates professionalism, cooperation, and willingness to support team and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- Knowledge of GLP and cGMP guidelines is required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
- The employee must occasionally lift and or move up to 25 pounds.
- The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.