Job Description
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!
Pay range $35 to $50 hr/W2 (NO C2C)
Onsite 100%
Hours: Monday to Friday (multiple shifts available )
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.
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.
Benefits
Medical, Dental, Vision, 401k
Weekly pay with direct deposit
Consultant Care support
Free Training to upgrade your skills
Dedicated Career Partner to help you achieve your career goals
If this is a role that interests you and you?d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands
Manpower, Experis, Talent Solutions, and Jefferson Wells
creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
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.
Our client in
Cambridge, MA, Kendall Square
is looking for hardworking, motivated talent to join their team. Two positions available!
Pay range $35 to $50 hr/W2 (NO C2C)
Onsite 100%
Hours: Monday to Friday (multiple shifts available )
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.
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.
Benefits
Medical, Dental, Vision, 401k
Weekly pay with direct deposit
Consultant Care support
Free Training to upgrade your skills
Dedicated Career Partner to help you achieve your career goals
If this is a role that interests you and you?d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands
Manpower, Experis, Talent Solutions, and Jefferson Wells
creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
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.
Key skill Required
- Manufacturing
- Ability To Read
- Accountability
- Analysis
- Care Support
- Compliance
- Continuous Process
- Demonstrated Ability
- Deviation Management
- Discipline
- DMAIC
- Documentation
- Investigation
- Management
- Orientation
- Packaging
- Pharmaceutical Manufacturing
- Root Cause Analysis
- Technical Writing
- TrackWise
- Training
- Troubleshooting
- Work Independently
- Writing
