The Quality Assurance Specialist is responsible for working in the Quality Assurance department providing technical knowledge, input, and support for commercial and developmental operations. Support general Quality Assurance related activities while maintaining compliance to the overall Quality Systems of the organization.

DUTIES AND RESPONSIBILITIES:

• Provide technical quality support for the validation of laboratory and manufacturing equipment such as stability chambers, HPLC’s, GC’s, filling/packaging, and testing equipment
• Technical review and analysis of facility design and validation protocols and related documentation such as utility water system, air handling, manufacturing area changes, etc.
• Assist with on-site training
• Provide technical engineering assessments and reviews of product-related cleaning and product/process validation activities
• Reviews and updates SOPs, Forms
• Technical review of manufacturing and quality documentation from vendors and management for consensus and approval.
• Work directly with department managers on investigations and CAPAs and assist in the review/approval of OOS investigations and CAPAs
• Assists management in the approval of document Change Controls (CCRs) related to all controlled documents.
• Reviews and approves qualifications with Supervisory oversight
• Perform QA technical document review of Validation, Research & Development, Manufacturing, and Quality documents.
• Writes, reviews, and revises SOPs, Protocols, and other company documents as required.
• Perform in process and end of process AQL inspections on devices, bottles, blisters, pouches, cartons, and labels.
• Provide quality review and disposition raw materials, clinical lots, and API intermediates
• Works under minimal supervision and performs functions that require a degree of creativity, latitude, and independence.
• Ability to utilize personnel and team resources for GMP related activities.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills):

• Bachelor of Science in Engineering, Chemistry, or related field; Life Science degree preferred or a combination of at least 5 years of training and experience
• At least 5 years of related experience in the pharmaceutical industry (commercial environment)
• Extensive GMP knowledge; Familiarity with GCP regulations; Knowledge and experience of the current requirements of FDA and ICH Guidelines along with hand-on experience managing regulatory inspections
• Must have a strong technical background and thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of Quality related issues
• Ability to utilize resources for GMP related activities (manufacturing, deviations, OOS’s)
• Must be willing to travel, approximately 10-20%
• Strong English written and verbal communication skills are required
• Ability to interact effectively in a team-based environment
• Ability to work independently and work with limited direction
• Experience with electronic QMS systems preferred

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person