Address
Form of work Position Details:
Our client, a world-leading Pharmaceutical Company in Kalamazoo, MI is currently looking for a Documents Specialist / Technical Writer / Pharma Manufacturing
to join their expanding team.
Job Title: Documents Specialist / Technical Writer / Pharma Manufacturing
Duration: 12 months contract, extendable up to 36 Months
Location: Kalamazoo, MI
Hybrid position. Must be local and able to work onsite as well as from home. Will work normal business hours
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
The Manufacturing Specialist-Documentation will develop documents and have responsibility for document review and approval in support of Drug Products Operations. Primary documents include SOP's, Batch Records, and Short Notice Changes.
This position will serve Drug Product Operations customers to develop or modify documents which enable the manufacturing process.
These may include SOP's, Batch Records, and Short Notice Changes.
Create/Revise documents to achieve clarity and efficiency in the manufacturing operations.
Documents may be developed in Microsoft Word or other batch record authoring applications.
Function as the responsible person for document changes, using Pharmaceutical's quality tracking system under GMPs and following all site procedures
Intake requests for change, create draft documents, confirm consensus and assure required approvals are completed on-time
Manage the timeliness of SOP Periodic Review
Track due dates and progress for assigned work, report off-track work
Organizational Relationships
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
Process Owners: Line Leads/Technical SMEs, Scientists, Process Engineers
Document Approvers: Quality Professionals, EHS Professionals, DP Training team, Drug Product Operations team leads
Drug Product Operations Document Team colleagues
Project Managers
Education And Experience
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
Bachelor's Degree with Minimum of 2 years of experience in a pharmaceutical setting including change control and formatting of documents
High School Diploma with Minimum of 7 years of experience in a pharmaceutical setting including change control and formatting of documents
Technical Skills Requirements
Indicate the technical skills required and/or preferred, as applicable.
Proficiency in use of PC and Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio) is required.
Technical writing expertise, strong facilitation, organizational skills, knowledge of applicable SOP's and GMP's preferred.
Proficiency in Microsoft Office required (Visio preferred)
Training and access in Quality Tracking System (Trackwise) preferred
Self-motivated with ability to manage workload and gather information in a dynamic environment
Comments:
Hybrid position. Must be local and able to work onsite as well as from home. Will work normal business hours.
Our client, a world-leading Pharmaceutical Company in Kalamazoo, MI is currently looking for a Documents Specialist / Technical Writer / Pharma Manufacturing
to join their expanding team.
Job Title: Documents Specialist / Technical Writer / Pharma Manufacturing
Duration: 12 months contract, extendable up to 36 Months
Location: Kalamazoo, MI
Hybrid position. Must be local and able to work onsite as well as from home. Will work normal business hours
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
The Manufacturing Specialist-Documentation will develop documents and have responsibility for document review and approval in support of Drug Products Operations. Primary documents include SOP's, Batch Records, and Short Notice Changes.
This position will serve Drug Product Operations customers to develop or modify documents which enable the manufacturing process.
These may include SOP's, Batch Records, and Short Notice Changes.
Create/Revise documents to achieve clarity and efficiency in the manufacturing operations.
Documents may be developed in Microsoft Word or other batch record authoring applications.
Function as the responsible person for document changes, using Pharmaceutical's quality tracking system under GMPs and following all site procedures
Intake requests for change, create draft documents, confirm consensus and assure required approvals are completed on-time
Manage the timeliness of SOP Periodic Review
Track due dates and progress for assigned work, report off-track work
Organizational Relationships
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.
Process Owners: Line Leads/Technical SMEs, Scientists, Process Engineers
Document Approvers: Quality Professionals, EHS Professionals, DP Training team, Drug Product Operations team leads
Drug Product Operations Document Team colleagues
Project Managers
Education And Experience
Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
Bachelor's Degree with Minimum of 2 years of experience in a pharmaceutical setting including change control and formatting of documents
High School Diploma with Minimum of 7 years of experience in a pharmaceutical setting including change control and formatting of documents
Technical Skills Requirements
Indicate the technical skills required and/or preferred, as applicable.
Proficiency in use of PC and Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio) is required.
Technical writing expertise, strong facilitation, organizational skills, knowledge of applicable SOP's and GMP's preferred.
Proficiency in Microsoft Office required (Visio preferred)
Training and access in Quality Tracking System (Trackwise) preferred
Self-motivated with ability to manage workload and gather information in a dynamic environment
Comments:
Hybrid position. Must be local and able to work onsite as well as from home. Will work normal business hours.
