Manufacturing Documentation Specialist

Overview:


TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.


Job Title: Manufacturing Documentation Specialist


Location: Portsmouth, NH, 03801


Duration: 8 Months


Job Type: Temporary Assignment


Work Type: Onsite

Summary:

The QA Documentation Specialist II / Manufacturing Documentation Specialist will be responsible for reviewing and approving GMP documentation supporting Manufacturing, Validation, MES, Quality Control, equipment and instrumentation, maintenance, and computer and analytical systems. This role serves as a QA subject matter expert, ensuring documentation, data integrity, quality, and regulatory compliance. The position will support quality-system activities, validation processes, and project-related activities while collaborating with internal stakeholders to identify, resolve, and escalate quality issues. The role will also support medium-to-large projects and ensure activities are completed accurately and within required timelines while maintaining cGMP, regulatory, quality, and safety standards.

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.

Required Skills:

• 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.
• Ability to work independently and collaboratively across departments.
• Ability to identify issues requiring escalation and take appropriate action.
• High attention to detail and ability to manage changing priorities.
• Ability to manage medium-to-large projects within required timelines.
• Strong customer-service and stakeholder-management skills.
• Ability to read, interpret, and follow SOPs, policies, and regulatory requirements.
• Strong commitment to GMP, quality, safety, and regulatory compliance.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.