SRG Government Services
Deviation Writer Job at SRG Government Services in Atlanta
SRG Government Services, Atlanta, GA, US, 30383
Deviation Writer
Title: Deviation Writer
Location: Marietta, GA
Industry: Pharmaceutical
Hours: M-F, 8am-5pm (with flexibility to start at 7am) and work longer hours as business dictates
Salary: Competitive within industry
Employment Type: Direct hire, 100% on-site
Environment:
Client is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing specialty products. Our diversified product portfolio in the specialty neurology and women's health space, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients' lives.
Position Overview:
Conduct and write formal investigation of process deviations for Manufacturing with the assistance of site personnel. This position will also perform initial and final impact risk assessment as well as assist in root cause determination and plan appropriate corrective action and preventative action. The incumbent will also assist in the tracking and trending of historical data and assure timely closure.
Responsibilities:
IND123
SRG4 Life Sciences delivers flexible staffing solutions nationwide, specializing in pharmaceutical, CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical, laboratory, and consumer product sectors. We provide contract, contract-to-hire, and direct hire placements across a wide range of critical roles including Scientists, Formulators, Engineers, QA/Regulatory Affairs, Microbiologists, Manufacturing Technicians, Supply Chain/Procurement Specialists, Project Managers, and Business Development professionals. SRG4 Life Sciences operates on a relationship-driven model-partnering closely with clients to understand not only the role, but the company's culture, goals, and vision. Our mission is to match purpose-driven professionals with organizations committed to advancing human health, building long-term partnerships that drive innovation, quality, and performance.
Title: Deviation Writer
Location: Marietta, GA
Industry: Pharmaceutical
Hours: M-F, 8am-5pm (with flexibility to start at 7am) and work longer hours as business dictates
Salary: Competitive within industry
Employment Type: Direct hire, 100% on-site
Environment:
Client is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing specialty products. Our diversified product portfolio in the specialty neurology and women's health space, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients' lives.
Position Overview:
Conduct and write formal investigation of process deviations for Manufacturing with the assistance of site personnel. This position will also perform initial and final impact risk assessment as well as assist in root cause determination and plan appropriate corrective action and preventative action. The incumbent will also assist in the tracking and trending of historical data and assure timely closure.
Responsibilities:
- Ensure compliance with relevant SOP's while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process and patient health and safety.
- As part of the investigation, gather information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufacturing product, as well as the risk to future operations.
- Leads and support investigations across Manufacturing, Packing and other departments to ensure timely closure for each investigation and follow-up activities.
- Works with the functional areas to identify the most probably root cause(s) and determine appropriate preventative and corrective actions.
- Trend and analyze product compliant investigation data and address appropriate as well as liaison with production and quality.
- Work independently to comply with procedure driven guidelines relating to deviation and complaint investigations.
- Bachelor's degree (Biology, Microbiology, Chemistry, Pharmacy or similar)
- 3-5 years related experience in a cGMP facility, pharmaceutical or related industry
- 3-5 years of deviation, investigative writer experience within FDA, pharmaceutical or related industry
- Proficiency with MasterControl for deviations is highly preferred
- Advanced writing skills
- Strong critical thinking and deductive reasoning skills
- Excellent interpersonal and communication (written and verbal) skills
- Strong MS Office skills
- Understanding of QA practices and standards is preferred
IND123
SRG4 Life Sciences delivers flexible staffing solutions nationwide, specializing in pharmaceutical, CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical, laboratory, and consumer product sectors. We provide contract, contract-to-hire, and direct hire placements across a wide range of critical roles including Scientists, Formulators, Engineers, QA/Regulatory Affairs, Microbiologists, Manufacturing Technicians, Supply Chain/Procurement Specialists, Project Managers, and Business Development professionals. SRG4 Life Sciences operates on a relationship-driven model-partnering closely with clients to understand not only the role, but the company's culture, goals, and vision. Our mission is to match purpose-driven professionals with organizations committed to advancing human health, building long-term partnerships that drive innovation, quality, and performance.