QA Specialist

Responsibilities

• Organize documentation and ensure ease of identification and retrieval.
• Aid in the issuance of purchase orders, invoices, and budget development.
• Assist managers in organizing, maintaining, writing, and reviewing GxP documents related to products, production, and CMO/CTO oversight.
• Compile, consolidate, and review documents to prepare for and/or release product, including Certificates of Analysis, Certificates of Conformance, Test and Batch Record Review Forms, Executed Batch Records, specifications, investigations, and change controls.
• Review deviations, CAPA, complaint investigations, and change controls for completeness, adequacy, and adherence to SOPs.
• Author/Review SOPs.
• Assist with tracking the stability & reference standard programs at contractors.
• Consolidate documentation/data for Annual Product Reviews (APRs) and trend stability data.
• Track activities and create monthly metrics.
• Support client/regulatory audits/inspections as Scribe and process requests for documentation.
• Help organize and prepare for audits/inspections.
• Helps to write/review observation responses.
• Review Status Updates to FDA.
• Perform additional duties as assigned by department management.
• Domestic and international travel possible.

Qualifications

• Essential skills include attention to detail; excellent organizational skills and critical thinking.
• Excellent communication skills - able to communicate clearly and concisely.
• Strong computer skills, including proficiency with MS Word, Excel, PowerPoint, and Outlook.
• Skills in SharePoint, Visio, and Oracle a plus.
• Education & Experience: 3+ years of experience in a GMP environment such as a Pharmaceutical Industry; Bachelor’s Degree in chemistry, life sciences, or related field with analytical laboratory experience a plus.

Benefits

• Annual Bonus
• Long-term Incentive Plan
• Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through CIGNA
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability Long-Term Disability (LTD), State (short term) disability - where applicable
• FSA (Flexible Spending Accounts) - Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off - Paid vacation, PTO, Holiday Notice

Compensation

Min USD $72,000.00/Yr. Max USD $81,000.00/Yr.