Location: Buena, NJ
Essential Duties and Responsibilities:
- • 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 investigations 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 circumstances where assistance is needed.
• Other duties as assigned.
Education and/or Work Experience Requirements:
- • Bachelor’s degree in Chemistry, Biological Science, Regulatory or equivalent, 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 Office 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.
• Good written and oral communication skills.
- • 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.