Associate Quality Assurance

Responsible for the maintenance of all required documentation for the Rhode Island site under the direction of Quality Management with coaching from the Document Management Subject Matter Expert. Provide comprehensive services in accordance with Good Manufacturing Practices (GMP) within Document Management with ability to flex support as needed within the Quality System space., * Maintain an active presence in the Document Management workroom and support internal and external processes related to record filing, archival, retrieval, and destruction.

• Manage Equipment Use Records, including ordering, issuance, and reconciliation.
• Support document archiving activities, including document organization, data entry, and preparation of materials for off-site storage.
• Lift, move, and organize boxes as needed; must be able to lift up to 50 lbs.
• Follow detailed, step-by-step instructions and perform repetitive tasks consistently and accurately.
• Respond to general questions, troubleshoot issues, and assist with complaint resolution as appropriate.
• Work effectively both independently and collaboratively within a team environment.
• Follow Current Good Manufacturing Practices (cGMP) regulations, as well as policies and procedures.
• Demonstrate the ability to work effectively in a fast-paced, rapidly changing, and demanding environment.
• Support additional projects and responsibilities as assigned.

Quality Assurance, Document Management, Reconciliation, Records Management, Support Documentation, Document Archiving, Off-Site Storage, Data Entry, Lift/Move 50 Pounds, Resolve Customer Issues, * Associates degree at a minimum. Basic GMP experience, Document management experience, Familiar with working within a regulated industry, Strong attention to detail.

Top 3 Must Have Skill Sets:

• Familiarity with working in a regulated industry with cGMP knowledge.
• Experience using MS Outlook, Word, Excel, and PowerPoint in an office setting.
• Strong attention to detail, organization, and ability to follow instructions.

Pay Transparency: The typical base pay for this role across the U.S. is: $28.00 - $28.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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