Over de functie
About the Job:
Perform Manufacturing investigative writing and technical writing, including but not limited to change controls, protocols, reports, and/or standard operating procedures/manufacturing batch records. The position requires working with minimal supervision to manage assigned tasks from initiation to completion. This is a desk job which may require you to stay seated for 6+ hours.
Independently responsible for the efficient and thorough investigation of process deviations, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process. Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, impact to product or patient/operator safety.
Responsibilities:
- Independently responsible for the efficient and thorough investigation of process deviations, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process.
- As part of each investigation, gathers information 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.
- Prepares and analyzes historical data and uses methodical root-cause analysis tools to determine and effectively communicate root causes.
- Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation has on the product, process, and patient health and safety.
- Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, impact to product or patient/operator safety.
- Provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
- Updates and maintains all related quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
- Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
- Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems.
- Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
- Perform any other tasks/duties as assigned by Manufacturing Management.
Maak het verschil
- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
- At least three years’ experience in a GMP manufacturing environment. Must be familiar with regulatory (FDA) requirements.
- Minimum 2 years experience with performing and documenting investigations and/or authoring standard operating procedures.
- Advanced writing skills, including experience with root cause analysis tools.
- Good deductive and inductive critical thinking skills with attention to detail and ability to manage multiple projects with shifting priorities.
- Must possess strong interpersonal, written, and verbal communication skills. Candidate must be able to interface positively with Regulatory Agencies, vendors, and company departments.
- Proficient in MS Office programs, including Word and Excel.
- Prefer candidates proficient with MasterControl QMS.
Wat bieden wij?
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
- Competitive Salary
- Health, Vision, and Dental Insurance
- Company Paid Life Insurance
- Generous Paid Holidays
- Paid Volunteer Time
- Generous Paid Time Off and Rollover
- Company matching 401K and Retirement Savings Plans
- Employee Assistance Program
- Flexible working arrangements
Now let's not forget our site!
The FSS Boston facility is in beautiful Canton, Massachusetts. Employees enjoy ample parking at a state-of-the-art compounding facility. The employee breakroom provides plenty of storage for lunches and you can enjoy free coffee anytime of the day!
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer