Jobs for People with MS: National MS Society

Pharmaceutical Deviation and Investigations Writer

Our client in Cambridge, MA, Kendall Square is looking for hardworking, motivated talent to join their team. Two positions available!

• Payrange $50-$54 hr/W2 (NO C2C)

• Onsite

• Full time (possibility for extension or perm conversion)

Hours: Monday to Friday (9hr/day) 08 AM to 05 PM

Job Description:

The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Technical Operations (Manufacturing, QC, and Engineering/Facilities departments.

Primary Responsibilities

• Perform investigation activities and writing deviation investigation reports for the Technical Operations (Manufacturing, QC, and Engineering/Facilities) department.

• Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.

• Write concise and accurate investigation reports.

• Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.

• Participate in determining the appropriate corrective and preventative actions ( CAPAs ) after the investigation process.

• Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.

• Initiate Change Controls as required for Manufacturing, QC, and Engineering/Facilities operations.

• Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.

• Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.

• Perform other related assignments and duties as required and assigned.

Education and Experience

• Requires a bachelor’s degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.

• Experience in GMP Biopharma organization

• Experience with SAP, Deviation systems

• Performing and documenting investigations using 5 Whys’, DMAIC,

• Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.

• Minimum of 3 years manufacturing or technical experience in a regulated GxP environment, oral solid dosage manufacturing/packaging preferred.

• Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.

• Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurate.

• Demonstrated ability to work independently and as part of a collaborative, cross-functional team.

• Working knowledge of TrackWise, SAP or similar deviation management system.

Click apply now!

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.