Permanent position: Investigative Writer needed for a amazing opportunity in the Buffalo, NY area with a high growth company. The Investigative Writer will be independently responsible for the investigation of process deviations and customer complaints, determination of root cause, and initiation of corrective/preventative actions designed to address and correct the Quality related deficiencies identified during the investigation process. Apply now for immediate consideration!Responsibilities for the Technical Writer
Requirements for the Technical Writer
- Responsible to provide proactive corrections based on documented trends to minimize repeated problems that may lead to the issuance of Product Discards, Field Actions, or Recalls.
- Responsible for ensuring compliance with relevant Standard Operating Procedures,
- Gathering, analyzing and applying information from internal and external sources to assess risk of the impact each process deviation and complaint has on the product, process, and patient health and safety.
- As part of each investigation, strong candidates would gather info from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
- Properly assess the manufacturing environment, independently advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.
- BA/BS Degree in science field, Biology, Microbiology, Chemistry, and Pharmacy, or equivalent combination of education and experience
- 3-5 years of pharmaceutical or related work experience
- Must understand GMP (Good Manufacturing Practices)
- Advanced technical writing ability required
- Candidate must possess strong interpersonal, written, and verbal communication skills. Candidates must be familiar with Regulatory Agencies, vendors, and company departments.
- Good knowledge of MS Office programs, including Word and Excel
- Excellent benefits package and relocation assistance available! Apply now!
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.