Location: Buena, NJ
Responsible for the writing of investigations for raw material, bulk, finished product commercial and pre-approval stability samples.
- Responsible for the writing/reporting, and design of the investigational studies.
- Responsible for maintaining all Laboratory Events paperwork.
- Responsible for writing laboratory Non-Conformance Reports (NCR) and Corrective Action and Preventative Action (CAPA) reports.
- Responsible for writing all interim reports needed for laboratory investigations, NCRs and CAPAs.
- Works closely each day with the QC supervisors in all laboratory areas and will write all RM/FP/Stab Investigations.
- Maintain the required cycle time of Investigations, coordinating all corrective actions and related document revisions pertaining to investigational conclusions.
- Requires a highly collaborative work style, with supervisory personnel as well as chemists.
- Keep the QC Supervisors and QC Manager informed of all key quality findings and issues as needed.
- Assumes other activities and responsibilities from time to time as needed/directed, this may include assisting other sub-groups in QC unit under special circumstance where assistance is needed.
- Bachelor’s degree, and a minimum of 4-6 years of bench/ technical related experience.
- Demonstrated ability to work on multiple projects and meet tight timelines.
- Knowledge of cGMP requirements.
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- Confident person with excellent organizational skills.
- Demonstrated ability to work on multiple projects and meet timelines. Detail oriented.
- Collaborative working style that can get along with diverse personalities.
- Demonstrates a high level of professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
- Strong interpersonal skills.
- Good written and oral communications.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- 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