Location: Buena, NJ
Responsible for supervising all investigations opened in the Quality Control unit and ensuring that timelines are met, and compliance is maintained. This role is also responsible for performing and reviewing investigations, determining root cause and initiating preventative/corrective actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process.
- Responsible for initiating, writing and reporting laboratory investigations for Raw Materials, Finished Products, Commercial and Pre-Approval Stability testing.
- Responsible for conducting in-depth interviews and gather pertinent information to drive to a root cause conclusion.
- Responsible for designing Phase I and Phase II retest plans as required.
- Responsible for approving Phase I and Phase II retest plans created by other Investigational Scientists.
- Responsible for maintaining compliance for all laboratory investigations. This includes the required cycle times, coordinating all preventative/corrective action and related documentation revisions pertaining to investigational conclusions.
- Responsible for issuing interim reports for any investigation when required.
- Responsible for the review of all laboratory investigations written by direct reports.
- Responsible for updating SOPs and maintain compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
- Works closely each day with the QC Managers/Supervisors in all laboratory areas.
- Responsible for tracking and trending of the investigation metrics each quarter.
- Requires a highly collaborative working style, with supervisory personnel as well as chemists.
- Keep the QC Supervisors and QC Managers 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.
- Experience authorizing investigations that cover Out of Specification (OOS) and Out of Trend (OOT) results.
- Exceptional writing and communication skills that can clearly convey investigational findings.
- Strong critical thinking and deductive reasoning skills.
- Excellent interpersonal and communications skills.
- Must be able to interface positively with Regulatory Agencies and company departments.
- 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.
- 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.
- 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