Manufacturing Documentation Specialist

Responsibilities

• Review and approve GMP documents, including SOPs, work instructions, eBRs, forms, checklists, and automation documentation.
• Review and approve validation and qualification documents for equipment, instrumentation, maintenance, computer systems, and analytical systems.
• Review and approve non-DMS documents, including preventive maintenance, CMMS forms, instrument data sheets, and facility forms.
• Document review observations, comments, and required corrections.
• Ensure document revisions and changes are properly justified and accurately reflected.
• Follow established documentation review, revision, and approval procedures.
• Escalate quality issues and concerns to senior QA specialists or management when required.
• Collaborate with internal customers to obtain information and resolve documentation issues.
• Participate in meetings, data queries, reporting activities, and project-related activities.
• Apply Data Integrity principles across all QA activities.
• Support quality systems involving deviations, change controls, CAPAs, OTN, and other quality events.
• Review and approve validation protocols and reports and support implementation of new equipment.
• Support medium-to-large projects and ensure completion within required timelines.
• Maintain compliance with cGMP, regulatory, quality, and safety requirements.
• Communicate effectively with QA, Manufacturing, Validation, MES, QC, Engineering, and other departments.

Requirements

• Bachelor of Science degree in a science-related discipline or equivalent relevant experience.
• 5-10 years of advanced experience in Quality Assurance, validation, biotechnology, pharmaceutical, or GMP environments.
• Extensive experience with QA and validation processes.
• Strong knowledge of GMP regulations, including ICH Q7 Q11 and applicable CFR requirements.
• Strong understanding of Data Integrity principles and practices.
• Experience with quality systems such as TrackWise, DMS, SAP, and/or Syncade.
• Knowledge of deviations, change controls, CAPAs, OTN, and other quality-system processes.
• Experience reviewing and approving equipment, process, cleaning, and computer-system validation documentation.
• Strong knowledge of Quality Control and manufacturing operations.
• Excellent documentation review and technical writing skills.
• Strong Microsoft Office skills, including Word, Excel, Outlook, and PowerPoint.
• Strong planning, organizing, project management, and time-management skills.
• Excellent analytical, problem-solving, and decision-making abilities.
• Strong written and verbal communication skills.
• Able to work independently and collaboratively across departments.
• Able to identify issues requiring escalation and take appropriate action.
• High attention to detail and ability to manage changing priorities.
• Able to manage medium-to-large projects within required timelines.
• Strong customer-service and stakeholder-management skills.
• Able to read, interpret, and follow SOPs, policies, and regulatory requirements.
• Strong commitment to GMP, quality, safety, and regulatory compliance.

Qualifications

TekWissen Group is an equal opportunity employer supporting workforce diversity. TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships. Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.