Location: Buena, NJ
Reporting Relationships: 2-4 Direct Reports
- Responsible for proper receipt and storage of materials for testing and release.
- Responsible for the sampling of the chemical raw materials for delivery to the laboratory for testing
- Responsible for the physical testing of componentry per established methods and acceptance criteria.
- Responsible for the review of raw data generated and approval of the data per procedures and documentation requirements.
- Responsible for reviewing/approving new monographs for the physical testing methods.
- Work closely with manufacturing, production and customer service to ensure timely release of materials for use in production.
- Issue supplier complaint investigation requests and perform investigations into non-conformances.
- Reject materials as required.
- Write and revise SOPs as needed.
- Responsible for maintaining compliance to GMPs in all areas.
- Assist in the compilation of documents for ANDA submissions.
- Train and mentor junior staff.
- Adhere to safety and housekeeping requirements.
- Keep Manager informed of all key quality findings and issues.
- Assume other activities and responsibilities from time to time as needed/directed.
- BS in Chemistry or related discipline, 3-5 years of pharmaceutical industry or laboratory experience.
- Strong foundation in analytical chemistry and quantitative analysis.
- Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- Excellent organizational skills.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
- Demonstrated ability to work on multiple projects and meet timelines.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- 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.
- The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
- 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.