Location: Buena, NJ
Reporting Relationships: One Direct Report
- Ensures that the day to day operations of the stability program for drug product, including stability sample set-down and pull requirements, ensuring a timely, effective and compliant operation to meet regulatory requirements.
- Responsible for reviewing/approving LIMS protocols, LIMS Registrations and LIMS Inventories.
- Responsible for responding to all alarms that go through the Rees Monitoring System and implementing corrective actions as required.
- Responsible for writing NCR’s and investigations when required.
- Oversees the log in and the delivery of stability samples to the appropriate laboratories in QC.
- Liaise with the department members as needed to accomplish tasks in a timely manner.
- Will be trained on how to perform data trending and graphing of stability data.
- Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
- Other duties as assigned.
- Minimum of a high school diploma, BA/BS preferred, with 2-4 years of experience in a cGMP/regulated environment or equivalent education and experience.
- Good communications skills and be experienced in Microsoft programs; Word, Excel, and Access.
- Excellent multi-tasking and organizational skills.
- Excellent 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.
- Strong interpersonal skills.
- Good written and oral communication skills.
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.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- 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.
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. 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.