Analyst III, QA Batch Release

1 month ago

Baltimore, United States BioSpace, Inc. Full time
Job Details

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

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 of Emergent BioSolutions at 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 Emergent 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

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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