- This role will provide non-testing support for raw material testing for new and existing product in a cGMP Quality Control Analytical (QCA) department.
- This support includes writing and revising technical documents (procedures, test methods, raw material specifications) for new and existing raw materials associated with cGMP testing, compendial updates, investigations, change controls, method verification/validation, LabWare Laboratory Information Management System (LIMS) support, visual management and continuous improvement.
- The candidate will be responsible documentation support as an individual and through collaboration with laboratory subject matter experts (SMEs). Organize and prioritize workload with manager to meet all timelines and deliverables in the support of the plan of record and to ensure compliance.
location: Andover, Massachusetts
job type: Contract
salary: $27.28 - 32.09 per hour
work hours: 9 to 5
- Revise and author GMP document
- Author GMP laboratory investigations
- Author change control documents
- Evaluate compendial changes and impact on GMP procedures and specifications
- Evaluate impact of changes on laboratory information management system (LIMS
- Create change requests for LIMS
- Support continuous improvement projects and actions
- Manage projects and coordinate timelines with stakeholders
- QC Analytical Management
- Material's Program Team (cross-functional)
- QC Microbiology
- QC Analytical Raw Materials laboratory analysts
- QC Analytical Raw Matertials validation scientists
- BS degree in science, engineering, computer science, or related technical discipline.
- Minimum 3-5 years pharmaceutical/bio-pharmaceutical experience in a relevant GMP role such as QC or QA
- Past experience working with QC documentation in the bio-pharmaceutical field is preferred
- Proficiency with computer systems (Microsoft Office applications, etc.)
- Experience with electronic document systems is highly preferred
- Knowledge and understanding of cGMP and industry standards
- Experience working in cGMP USP/EP/JP, regulatory environment strongly preferred
- A detail-oriented approach to deliverables as the main job responsibility is generation and revision of GMP documentation
- Strong oral and written communication skills
- Ability to work in a matrix environment
- Ability to adapt to change in priorities and timelines
- Dedicated and team orientated who is highly motivated and takes initiative, seeks out assignments
- Document Specialist with GMP Pharma experience
- Write change controls, protocols, investigations
- SOP and documentation experience
- Support raw material department
- QC lab knowledge, authorize doc, writing investigations, writing change controls. use of electronic documentation systems.
- 2-5 years of experience in Pharma/ Biopharma
skills: Quality control, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.