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QA Document Writer
$1,000 SIGN-ON BONUS
Verona, WI
Job Description
POSITION OVERVIEW:
The QA Document Writer is responsible for revising and maintaining a variety of documents for use in a cGMP manufacturing environment, primarily in the processing areas. This position entails working within an established change management program governed by SOPs to ensure proper control. This position will interact in collaborating with subject-matter experts to ensure the procedures are accurate, well-written, and completed in a timely manner. This position will perform administrative support activities for Document Control and the QA Department.
Coating Place, Inc. pays a $1,000 Sign-On Bonus for new employees after completing one year of employment.
ESSENTIAL JOB FUNCTIONS:
EDUCATION/SKILLS/KNOWLEDGE REQUIRED
The QA Document Writer is responsible for revising and maintaining a variety of documents for use in a cGMP manufacturing environment, primarily in the processing areas. This position entails working within an established change management program governed by SOPs to ensure proper control. This position will interact in collaborating with subject-matter experts to ensure the procedures are accurate, well-written, and completed in a timely manner. This position will perform administrative support activities for Document Control and the QA Department.
Coating Place, Inc. pays a $1,000 Sign-On Bonus for new employees after completing one year of employment.
ESSENTIAL JOB FUNCTIONS:
- Revise a variety of existing production documents in accordance with internal specifications, manufacturing and project requirements, while verifying accuracy.
- Interact with department and subject-matter experts to revise and finalize Master Production Record documentation.
- Adhere to the established change management program, including effective document review and approval flow, to ensure successful release of new/revised documents.
- Perform assigned document control activities, such as, but not limited to creation and revision of standard operating procedures and collecting data for insertion into reports and investigations
- Perform batch production document review, as required for consistency, critical elements, etc.
- Serves as a backup for issuance of production documents and final product labels.
- Perform retrieval activities from the vertical file storage (VFS) system or other locations as needed for client/regulatory audits and internal customer requests.
- Follows all CPI cGMP and safety practices, policies, and procedures.
- Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED
- Bachelor's Degree in a Science or Quality related field, preferred.
- Demonstrated knowledge of cGMPs, FDA, and other regulatory agency requirements.
- Proficiency in Microsoft Office (Word and Excel), SharePoint preferred.
- Ability to communicate both verbally and in writing across all levels of the organization, internally and externally.
- Ability to mutli-task and work in a deadline-driven environment.
- Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
- Excellent organizational and multi-tasking skills.
- Sound practical judgment of priorities and high attention to detail.
- A continuous improvement and quality mindset.
- Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40+
Work Hours (i.e. shift)
1st Shift
Salary and Benefits
Based On Experience
Required Education
Bachelor's Degree
Required Experience
Open
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