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Sirius Staffing
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Bailee Stevens
Technical Writer
Job Description
Sirius Staffing is seeking a Technical Writer working a Hybrid work schedule in Birmingham, AL for a 1 year contract. Please contact us today for more information.
The Technical writer role is intended to support the clerical aspect of Good Manufacturing Practices (GMP) through document drafting, updating, routing, and coordinating the timing of these activities against business needs. These documents may support any aspect of the total manufacturing process including—but not limited to—Master Batch Production Records, Material Specifications, Procedures, Work Instructions, Protocols, and Forms.
Maintain a level of ownership of site supporting systems including document control systems, quality management systems, network drives, software-based organizational channels, etc.
Responsibilities:
- Responsible for workplace safety, training, environmental compliance, adherence to quality process/procedures, and area housekeeping.
- Responsible for tactical batch execution readiness including (but not limited to) initiating/coordinating change controls in quality systems, executing document generation/revisions, overseeing document reviews/approvals in document management systems, and driving other groups to complete their portions within this process.
- Providing clerical review of executed batch records and other completed documents for adherence to site quality standards.
- Strategic batch execution readiness including (but not limited to) providing updates in planning meetings regarding forecasted timelines, looking many months in advance to ensure readiness steps begin in a timely manner, area performance trending / reporting, post process continuous improvement through after-action review, and other process improvement duties as needed to achieve functional objective and targets.
- Seek out and identify opportunities for improvement in the areas of GMP document management, training, execution, deviation causal factors, and product release
- Contribute to Departmental metrics data entry; Area and unit operation process performance trending / reporting
Qualifications:
- Degree (Preferably BA/BS) in STEM subject and/or where technical writing was required
- Excellent written, verbal, organizational, and people skills
- Proficient in Microsoft Word. Basic understanding of all other Microsoft Office software.
- Ability to learn enterprise computer-based software (e.g. Regulus, TrackWise, SAP, etc.)
- Ability to interact and communicate effectively with production operators and senior management regarding aspects of past, present and future manufacturing unit operations and improvements
- Ability to display a competent level of understanding of operational requirements for cleanrooms in highly regulated environments pharmaceutical
- Ability to multi-task and manage complicated, dynamic manufacturing activities in multiple locations on time and on/under budget while also managing other job-related tasks/activities
- Relevant industry experience in GMP style environment
- Basic knowledge of the scientific principles pertaining to standard processing and manufacturing equipment.
Sirius Staffing is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
Meet Your Recruiter
Bailee Stevens
Recruiting Manager
Bailee Stevens is a recruiter bringing a wealth of experience and a genuine passion for building relationships and helping talent find career opportunities. With 14 years’ experience in the industry, she has learned the importance of finding the perfect fit for both candidates and clients. Bailee takes pride in effectively communicating and making a meaningful impact on people’s careers and lives. She has expertise in working in many different industries from Manufacturing, Industrial, Energy, Aviation, Oil and Gas, Automotive, Government, Marine/Shipbuilding, and more. Bailee has been successful in recruiting talent for many different types of positions such as Professional, IT, Logistics, Procurement, Finance/Accounting, Administrative, Light Industrial, Engineering, Healthcare roles, and more.
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About Birmingham, AL
Discover Your Next Career Opportunity in Beautiful Birmingham, Alabama! This vibrant city nestled in the heart of the South offers a perfect blend of Southern charm and modern amenities. Known for its rich history, delicious southern cuisine, and thriving arts scene, Birmingham is a hidden gem for job seekers looking to grow their careers. Explore job opportunities near iconic landmarks like the Vulcan Park and Museum, catch a show at the Alabama Theatre, or cheer on the Birmingham Barons at Regions Field. With its lush parks, trendy galleries, and bustling cultural events, Birmingham provides an exciting backdrop for your professional journey. Start your job search today and experience the magic of Birmingham!
