Current jobs related to Manufacturing Deviation and Investigations Writer - Cambridge - Experis
-
Cambridge, United States The Accuro Group Full timeBusiness Title: 104241 | Facilities Engineering Technical/Deviation Writer Location: Cambridge, MA 02142 Job Type: Contract (6 M+) Note: Hybrid Position. Job Description: The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Engineering, Facilities and Validation...
-
Technical Writer
4 weeks ago
Cambridge, United States eTeam Full timePOSITION TITLE: Technical Writer/Deviation WriterLocation: Cambridge, MADURATION: 6 MonthsPay Rate: $62.82/hr on W2Job Description:The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the FEV (Facilities, Engineering and Validation) department, as well as revising and writing...
-
Technical Writer
4 weeks ago
Cambridge, United States Alphanumeric Systems Inc. Remote Work Freelance Full time $58 - $61Alphanumeric is hiring a Facilities Engineering Technical/Deviation Writer to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.The Tech Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the FEV...
-
Technical Writer
3 weeks ago
cambridge, United States APR Consulting Full timeA healthcare client is looking for a Facilities Engineering Technical/Deviation WriterLocation: Cambridge, MA 02142Position: Facilities Engineering Technical/Deviation Writer Pay Rate: $59/hrDuration: 6 months Expected Shift: Monday – Friday 8-5pmHYBRID: 4 days on site/1 day at home per weekJob Description:The Tech Writer is responsible for performing GxP...
-
Technical Writer
4 weeks ago
cambridge, United States APR Consulting Full timeA healthcare client is looking for a Facilities Engineering Technical/Deviation WriterLocation: Cambridge, MA 02142Position: Facilities Engineering Technical/Deviation Writer Pay Rate: $59/hrDuration: 6 months Expected Shift: Monday – Friday 8-5pmHYBRID: 4 days on site/1 day at home per weekJob Description:The Tech Writer is responsible for performing GxP...
-
Technical Writer
4 weeks ago
Cambridge, United States APR Consulting Full timeA healthcare client is looking for a Facilities Engineering Technical/Deviation WriterLocation: Cambridge, MA 02142Position: Facilities Engineering Technical/Deviation Writer Pay Rate: $59/hrDuration: 6 months Expected Shift: Monday – Friday 8-5pmHYBRID: 4 days on site/1 day at home per weekJob Description:The Tech Writer is responsible for performing GxP...
-
Technical Writer
4 weeks ago
Cambridge, United States APR Consulting Full timeA healthcare client is looking for a Facilities Engineering Technical/Deviation WriterLocation: Cambridge, MA 02142Position: Facilities Engineering Technical/Deviation Writer Pay Rate: $59/hrDuration: 6 months Expected Shift: Monday – Friday 8-5pmHYBRID: 4 days on site/1 day at home per weekJob Description:The Tech Writer is responsible for performing GxP...
-
Facilities Engineering Technical Writer
3 weeks ago
Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full timeAbout the RoleWe are seeking a highly skilled Facilities Engineering Technical Writer to join our team at Alphanumeric Systems Inc. in Cambridge, MA. As a Facilities Engineering Technical Writer, you will be responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the FEV department.Key...
-
Facilities Engineering Technical Writer
4 weeks ago
Cambridge, Massachusetts, United States The Accuro Group Full timeJob Summary:The Accuro Group is seeking a skilled Facilities Engineering Technical Writer to join our team. As a key member of our Engineering, Facilities, and Validation departments, you will be responsible for performing GxP investigation activities and owning and authoring deviation investigation reports.Key Responsibilities:Perform investigation...
-
Facilities Engineering Technical Writer
2 weeks ago
Cambridge, Massachusetts, United States APR Consulting Full timeJob Title: Facilities Engineering Technical WriterLocation: Cambridge, MAJob Type: Full-timePay Rate: $59/hrDuration: 6 monthsShift: Monday – Friday 8-5pmHybrid: 4 days on site/1 day at home per weekJob Summary:The Facilities Engineering Technical Writer will be responsible for performing GxP investigation activities and owning and authoring deviation...
-
Facilities Engineering Technical Writer
2 weeks ago
Cambridge, Massachusetts, United States The Accuro Group Full timeJob Title: Facilities Engineering Technical WriterCompany: The Accuro GroupLocation: RemoteJob Type: Contract (6 months+)Job Description:The Technical Writer will be responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Engineering, Facilities, and Validation departments. As a key member of...
-
Regulatory Documentation Coordinator
3 weeks ago
Cambridge, Massachusetts, United States The Accuro Group Full timeJob Summary:The Accuro Group is seeking a skilled Facilities Engineering Technical Writer to join our team. As a key member of our Engineering, Facilities, and Validation departments, you will be responsible for performing GxP investigation activities and owning and authoring deviation investigation reports.Key Responsibilities:Perform investigation...
-
Cell Therapy Manufacturing Specialist
2 weeks ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeCell Therapy Manufacturing OpportunityVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a skilled manufacturing professional to contribute to the production of commercial cell therapy products.Key Responsibilities:Execute process steps to manufacture cell therapy products meeting internal and...
-
Manufacturing Quality Assurance Specialist
4 weeks ago
Cambridge, Massachusetts, United States The Accuro Group Full timePosition Title: | Manufacturing Quality Assurance SpecialistLocation: RemoteJob Type: Contract (12 Months)Note: Parking expenses are not covered by the organization.Important: A background in manufacturing is essential.Position Overview:The Accuro Group is a leading biopharmaceutical organization dedicated to advancing science, technology, and talent to...
-
Lead Medical Writer
4 weeks ago
Cambridge, Massachusetts, United States Prometrika LLC Full timeJob OverviewPROMETRIKA LLC is a comprehensive clinical research organization (CRO) with a wealth of expertise in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. Our commitment is rooted in the human element of our endeavors and our empathy for individuals whose lives have been enhanced by the advancements we...
-
Senior Medical Writer
2 months ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Cell Therapy Manufacturing Associate
5 days ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeManufacturing Associate - Cell TherapyVericel Corporation, a leading innovator in advanced therapies, is seeking a skilled Manufacturing Associate to join our team. As a key member of our manufacturing team, you will play a critical role in the production of commercial cell therapy products.Key Responsibilities:Execute process steps to manufacture cell...
-
Medical Writer I
2 months ago
Cambridge, United States Prometrika LLC Full timeJob DescriptionJob DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the...
-
Manufacturing Associate I
2 weeks ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeVericel Corporation, a leading biotechnology company, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics.Job SummaryResponsible for the execution of process steps to manufacture...
-
Associate I, Cell Therapy Manufacturing
1 month ago
Cambridge, United States Vericel Corporation Full timeJob DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing manufacturing professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty...
Manufacturing Deviation and Investigations Writer
4 months ago
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 )
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.
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.
- 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.
