Biologics Documentation Specialist

Job Title: Biologics Documentation Specialist Location: Remote Duration: 12 Months Job Description: Compile, submit, assemble, and track documents Documents formatting Microsoft Office Suite Understanding of One Vault system General Understanding of chromatography, filtration, cell culture, purifications, cleanroom (biologics processing/bioprocessing operations) Understanding of GMP change control Technical degree in Chemistry or Biology or Chemical Engineering with 5-10 years of biologics manufacturing experience Top 3-5 skills requirements 1) Strong technical understanding of general biologics manufacturing unit operations, aseptic processing skills, and the nomenclature utilized in biologics manufacturing (facility, utility and equipment) (2) Advanced understanding of the ‘One Vault’ Quality Documentation Management System (3) Advanced understanding of documentation change control, documentation processing and administrative tasks with processing a document from draft status to Approved status to Effective status (4) Advanced understanding of biologics contamination risk, mediation of contamination risk and a background in biologics laboratory &/or manufacturing operations (5) Technical degree in Chemistry or Biology or Chemical Engineering with 5-10 years of biologics manufacturing experience Preferred Experience: Knowledge and hands-on experience with Document Management Systems; Experience in detail-intensive and customer-focused environments; Excellent organizational skills, attention to detail, and strong oral and written communications skills; Word processing knowledge and experience with Microsoft Office products Best Regards, Deepak Singh Tomar Cell: 612-355-6533 Deepakt(at)selectsourceintl(dot)com Disclaimer: Select Source International (SSI) does not tolerate discrimination against any applicant on the basis of gender, sexual orientation, race, religion, national origin, ethnicity, veteran status, disability, age, sexual preference or any other protected status designated by federal, state or local law. It is SSI’s policy to affirmatively recruit, hire, train, assign, transfer, evaluate, compensate, provide benefits, promote, demote, layoff, recall, and terminate employees on their own abilities, achievements and experiences. This policy applies to all SSI employee activities. SSI encourages diversity in hiring, recognizing that this enriches the work environment for all SSI associates and that a broad variety of perspectives enhances decision-making and creativity. SSI is an Equal Opportunity Employer. Job Type: Contract Pay: $28.00 - $30.00 per hour Expected hours: 40 per week Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Associate (Required)

Experience:

• biologics manufacturing: 5 years (Required)
• One Vault Quality Documentation Management System: 2 years (Required)
• chromatography, filtration, cell culture, purifications: 2 years (Required)

Work Location: Remote Apply Job!