Analyst III Quality Assurance

JOB SUMMARY

The Analyst III, Quality Assurance is responsible for Quality oversight of processes occurring at the Baltimore facility which include management of quality systems (CAPA, Deviations, Complaints Risk Management and Change Controls) as it relates to compliance activities (Audits, APRs & Regulatory

Surveillance).

Support internal and external Quality Systems, such as facility/equipment, materials, production, laboratory, packaging/labeling, final drug product review, and quality. Supports internal and external customers. Assure compliance with current GMPs

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Supports the Quality Systems department in various tasks associated with eQMS processes.
• Critically review complex records (e.g., stability data, complaint investigations, CAPA.
• Plans, deviation investigations etc.) to ensure completeness, accuracy and compliance.
• Provide audit support during client/regulatory inspections for Quality Systems. This includes compiling Quality Systems Data during inspections and writing audit responses as assigned.
• Compile Quality Systems data for Annual Product Reviews (APRs). This includes providing Quality Systems data for specific products and writing reports as deemed necessary.
• Support Risk Management program by identifying and evaluating potential regulatory risks and working with the appropriate department(s) in mitigating potential risks that could impact the quality of product, service, or process within our organization.
• Serves in a decision-making capacity on major document changes, deviations corrective and preventive actions, change controls and other projects.
• Exercises judgment within defined procedures to determine appropriate action for resolution of quality issues.
• Writes moderately complex technical documents.
• Assist in the maintenance of quality plans, including tracking and advancing initiatives, routinely reporting progress and maintaining documentation as it relates to Quality Systems.
• Compile and report performance metrics for Deviations and other relevant Quality Systems activities.
• Revise Standard Operating Procedures and Forms, as needed.
• Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
• Participates in relevant lean and operational excellence activities.
• Resolves a wide range of issues in creative ways. Defines appropriate actions and requirements for resolution of issues.
• Provide logistical support and technical knowledge during regulatory and internal inspections of Bora's quality systems.
• Communicates effectively with management project status, issues and mitigations
• Maintain company quality and safety standards.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BS degree in Chemistry/Biology or related discipline with 4-6 years GMP experience required,
• 2-3 years Quality Assurance experience required.
• MS degree in Chemistry/Biology or related discipline with at least 2 years Quality Assurance experience may be substituted.
• Proficient knowledge of cGMP, minimum of 1 year Audit or Regulatory experience.
• Strong attention to detail and the ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Strong communication skills (written and verbal) and strong organizational skills.
• High level of personal/departmental accountability and responsibility.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to use computer programs such as Access, Excel, SAP and an electronic document management system.
• Ability to work in a team environment and to work within that team to maximize efficiency and throughput.

Compensation Range:
$75,789.00 - $113,684.00
Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category