Quality Assurance Specialist I, QA Operations

ROLE SUMMARY

The QA Specialist is responsible for ensuring that quality requirements are established and maintained in accordance with the appropriate regulations and cGMP guidelines. This role is to act as a quality liaison to other departments within the company. The specialist is a model to junior associates through exhibition of high productivity, accuracy, and flexibility, including maintaining a positive attitude regardless of circumstances. Good documentation, organizational, written, and verbal communication skills are required. The specialist must have schedule flexibility and/or work overtime as required.

ROLE RESPONSIBILITIES

• Approve or reject manufactured intermediate materials for further manufacturing use
• Approve or reject all procedures, specifications, and changes impacting on the identity, strength, purity, and quality of drug products
• Review manufacturing records and ensure all discrepancies and deviations have been documented and investigated
• Conduct and approve investigations for deviations for quality systems
• Assist with the coordination of audits of the site by regulatory authorities and partners; may interact with auditors as a subject matter expert for the specialist’s areas of expertise
• Disposition raw materials used in manufacturing
• Provide QA support for quality issues/concerns that arise within the site
• Review stability data/reports
• Write and revise SOPs related to Quality Assurance
• Assist with visual inspection of vials and labeled/packaged product materials as needed
• Review environmental, personnel, purified water, and clean steam monitoring results
• Maintains the QA Document Archive and active quality system files in an inspection-ready state
• Develops and maintains subject matter expertise in one or more quality systems
• Holds self and others responsible to abide by department and company policies and practices
• Qualify as trainer for quality systems for training less experienced staff
• Develops familiarity concerning cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements as required
• Provide trend analysis and critical thinking to the performance and effectiveness of quality systems as needed
• Provide product shipping support, including generation of shipping documents and coordination with transport couriers

SKILLS

• Maintains ability to follow written instructions and to perform tasks with minimal supervision
• Works independently as well as in a team environment
• Is proficient in Microsoft Windows, Word, Excel, etc
• Excellent written and verbal communication skills
• Possesses strong documentation skills
• Maintains ability and willingness to engage in active and open discussion, and laying the groundwork for logical decision-making, in any assigned quality task
• Experience with cGMP environments and quality systems required
• The employee must occasionally lift and/or move up to 25 pounds
• Specific vision abilities by this job include close vision, depth perception and the ability to adjust focus

QUALIFICATIONS

• B.S/B.A in Science/Related Field (major in biology-biochemistry-chemistry). 7-10 years of relevant quality system experience is desired
• MS Degree in Science/Related Field (major in biology-biochemistry-chemistry) .4-8 years of relevant quality system experience is desired
• PhD in Science/Related Field (major in biology-biochemistry-chemistry). 3-5 years of relevant quality system experience is desired