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About this Job
Location: Portsmouth, NH (Onsite)
Length: 9 Month Contract
Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available
Job Description:
The QA Specialist II is responsible for the review and approval of GMP documentation supporting site operations, including Manufacturing, Validation, MES, and Quality Control. This role serves as a subject matter expert for QA document review related to equipment and instrumentation, validation maintenance, and computer and analytical systems, and may also support customer-specific documentation. The QA Specialist III works closely with QA colleagues, QA project managers, management, and internal customers to support documentation and projects, resolve quality issues with supervision as needed, and provide strong customer service while escalating items appropriately.
Essential Duties and Responsibilities:
- Independently review and approve initial and revised documents in a document management system, including SOPs, Work Instructions, eBR and automation documentation, forms, checklists, scanned documents, and other related records as needed.
- Review and approve electronic and/or paper validation and qualification documents, including protocols and summary reports for equipment/instrumentation, validation maintenance, and relevant computer and analytical systems.
- Review and approve non-DMS documents such as QA monthly preventative maintenance documents, engineering preventative maintenance documents, CMMS forms, instrument data sheets, functional equivalent memos, DMS withdrawal forms, periodic review audit trail documents, and miscellaneous facility forms.
- Document review observations, including suggested edits and comments, when applicable.
- Follow documentation review procedures and ensure changes are justified appropriately and accurately reflected in the document.
- Follow associated documentation revision and review procedures and escalate issues or concerns to senior QA leadership or management as needed while working with internal customers to gather information required to resolve them.
- Participate in routine meetings, data queries, and report section compilation as assigned by management.
- Apply data integrity principles in all aspects of work in compliance with applicable policies, guidelines, and procedures.
Qualifications:
- Bachelor of Science in a science-related discipline, or relevant experience in the field.
- 5 to 10 years of experience in quality assurance, biotech, pharma, or a GMP environment.
- Experience with quality assurance and validation processes.
- Strong understanding of CSV validation guidelines, templates, and SOPs.
- Strong written and verbal communication skills, including the ability to work effectively across multiple levels of the organization.
- Experience with document management systems and other enterprise systems such as DMS, TrackWise, SAP, or Syncade preferred.
- Working knowledge of GMPs and regulations preferred, including ICH Q7-Q11 and applicable CFR requirements.
- Strong attention to detail, sound decision-making, and the ability to manage multiple priorities.
- Ability to work independently, collaborate across departments, and identify items that require escalation.
- Proficiency with Microsoft Office tools, including Word, Excel, Outlook, and PowerPoint preferred.
- Demonstrated ability to support medium to large projects within required timeframes.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Come see why DPC has achieved:
4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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