Analyst III, Quality Assurance-Batch Release
: Job Details :

I. JOB SUMMARY The QA Analyst III is responsible for performing duties related to the management of records relevant to the review and release of Batch Records for the cGMP operation at Bora Pharmaceutical, the Baltimore Camden Site. Our QA Department provides expertise in problem solving and process improvements. The QA Analyst will interact with all departments to provide guidance necessary to maintain and improve cGMP compliance at the company.II. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.Batch Review and Release• Critically reviews GMP documents such as: o Executed batch records for a variety of different functional areaso Analytical Testing Datao Microbial and Environmental Monitoring Datao WFI testing datao Equipment Data o Logbooks• Perform SAP Transactions• Address and respond to client comments in a timely manner• Conduct Product Disposition meetings and subsequent follow-up information from the meetings• Analyze and publish department metrics• Post release batch data entry• Review of documentation and authorization of shipments• Review and filling of Ancillary forms• Scanning and filling of released batch records• Initiate non-conformance investigations• Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.Quality Operations Support: • Compile and report performance metrics for Batch Review and Release relevant activities.Continuous Improvement• Identify opportunities for improvement within scope of work.• Participate in operational excellence activities. Regulatory Inspection• Provide logistical support and technical knowledge during regulatory and internal inspections of Bora Pharmaceutical quality systems.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. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS• BS degree in Chemistry/Biology or related discipline with 1-3 years Quality Control or Quality Assurance experience or a MS degree in Chemistry/Biology or related discipline with at least 1-year Quality Assurance experience, preferred. • 1 year in an FDA regulated industry is preferred.• Must have strong attention to detail.• Ability to manage multiple priorities and tasks in a dynamic environment.• Excellent written and verbal skills.• Ability to exercise judgment to determine appropriate corrective actions.• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.• Ability to use computer programs.• Ability to work in a team environment.• Working knowledge of cGMP. • Ability to make sound decisions regarding compliance-related issues with moderate supervision.IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICSThe physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.Compensation Range:$75,789.00 - $113,684.00Bora 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