What are the responsibilities and job description for the Technical Document Reviewer - Aseptic Fill/Pre-Filled Syringes position at Automated Systems Inc.?
Technical Document Reviewer - Aseptic Fill/Pre-Filled Syringes
Location: Pleasant Prairie, WI - Onsite
Contract: 9–12-month duration with potential for extension
Position Overview:
Automated Systems, Inc. is seeking experienced Technical Document Reviewers to support an aseptic fill facility specializing in the manufacture of pre-filled syringes. This contract position (9-12 months) requires professionals with a strong understanding of quality assurance, engineering, and manufacturing processes in a regulated pharmaceutical environment. The reviewers will be responsible for ensuring the accuracy, compliance, and completeness of critical documents to maintain operational and regulatory excellence.
Key Responsibilities:
Review and Approve:
· Standard Operating Procedures (SOPs)
· Policies and Work Instructions
· Batch Records and Manufacturing Protocols
· Deviation Reports and Change Controls
Ensure Compliance:
· Verify alignment with cGMP, FDA, and other applicable regulatory requirements
· Assess document accuracy from a quality assurance (QA), engineering, and manufacturing perspective
· Identify inconsistencies, discrepancies, or gaps and recommend corrections
Cross-Functional Collaboration:
· Work closely with QA, validation, manufacturing, and engineering teams to address document issues and ensure alignment with operational requirements
· Provide timely feedback to document authors to maintain project timelines
Document Control & Version Management:
· Ensure documents adhere to established document control processes
· Verify proper version control and adherence to revision/change control procedures
Education, Experience Qualifications:
· Bachelor’s degree in engineering, Life Sciences, Quality, or a related field
· Minimum of 5 years of experience in pharmaceutical manufacturing, aseptic processing, or quality assurance
· Prior experience reviewing technical documents in an aseptic fill environment (preferred)
· Familiarity with pre-filled syringe manufacturing processes
Knowledge & Skills:
· Strong understanding of cGMP, FDA, and other regulatory compliance requirements
· Ability to identify quality, engineering, and manufacturing concerns during document reviews
· Excellent attention to detail and analytical skills
· Strong communication and interpersonal skills to engage with cross-functional teams
Job Types: Full-time, Contract
Pay: $28.50 - $34.50 per hour
Expected hours: 40 per week
Benefits:
- Dental insurance
- Flexible spending account
- Health insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- No weekends
Work Location: In person
Salary : $29 - $35
