QA Assistant

Union Agener, Inc.; Augusta (GA); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

401(k) with company match

Vacation program

Career growth opportunities

Job summary

Union Agener, Inc. seeks a Documentation Specialist to print and issue batch records and labels for all manufacturing operations, execute document requests, and act as the documentation steward ensuring coordinated reviews and releases.

You will maintain training modules and SOPs, manage archive and distribution, support cGMP compliance, and assist with data integrity across spreadsheets and databases in a fast-paced pharmaceutical setting.

Qualifications

• Three (3) years of experience in Quality Control or Quality Assurance
• Demonstrated knowledge/application of cGMPs and other pharmaceutical guidelines
• Detail oriented, results oriented and strong interpersonal skills
• Excellent communication and organization skills
• Ability to work effectively with respect for others in a team environment
• Proficiency with Microsoft Excel/Word and SAP knowledge
• High school diploma or GED; associate degree preferred

Responsibilities

• Print and issue batch records and labels for all manufacturing operations
• Execute Document Requests to Create, Revise, Cancel, or Print
• Act as a documentation steward (ensures a coordinated review of all associated documents)
• Perform document release (ensures a coordinated release of all associated documents)
• Perform document distribution (controlled copy), communication (email), and archive
• Act as archive room manager
• Support Training Module Management (courseware request, roster inquiries, processing credits, test answer keys)
• Maintain training modules and SOPs related to documentation activities
• Spreadsheet and database maintenance

Skills

Detail oriented

Results oriented

Strong interpersonal skills

Excellent communication

Excellent organization skills

Adapt readily to change

Education

High School Diploma or GED

Associate's degree in a technical related field

Tools

Microsoft Excel / Word proficiency

Knowledge of SAP

Job description

Position Description, Functions, Duties and Tasks:

• Print and issue batch records and labels for all manufacturing operations
• Execute Document Requests to Create, Revise, Cancel, or Print
• Act as a documentation steward (ensures a coordinated review of all associated documents)
• Perform document release (ensures a coordinated release of all associated documents)
• Perform document distribution (controlled copy), communication (email), and archive
• Act as archive room manager
• Support Training Module Management (i.e. courseware request, roster audience inquiries, processing course credits, test answer keys (SOP or module))
• Maintain training modules and SOPs related to documentation activities
• Spreadsheet and database maintenance

Minimum Qualification (Education, Experience and/or Training, Required Certifications):

Education:

• Minimum of a High School Diploma or GED
• Preferred Associate's degree in a technical related field

Experience:

• Three (3) years of experience in Quality Control or Quality Assurance
• Demonstrated knowledge/application of cGMPs and other pharmaceutical guidelines

Additional Preferences:

Required Skills:

• Detail oriented
• Results oriented
• Solid computer skills (word processing, database, etc)
• Strong interpersonal skills
• Ability to work effectively with respect for others in a team environment
• Excellent communication
• Excellent organization skills
• Adapt readily to change and have the desire to experience new challenges and opportunities

Preferred Skills:

• Microsoft Excel / Word proficiency
• Knowledge of SAP
• Adapt readily to change and have the desire to experience new challenges and opportunities

Physical Demand Requirements:

• Those associated with sedentary work
• Must be able to climb stairs and ladders when required
• Must be able to perform and review work in a manufacturing plant environment

What do we offer?

• Competitive Salary
• Competitive Benefits Package and Employee Assistance Program
• 401(k) Plan + Company Match
• Vacation + End of Year Vacation (Company Sponsored)
• Growth Opportunities to expand your career