Job Description
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 FUNCTIONS
Reasonable 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 areas
o Analytical Testing Data
o Microbial and Environmental Monitoring Data
o WFI testing data
o 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 CHARACTERISTICS
The 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 - $113,684.00
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 Bora Pharmaceuticals
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