Senior Quality Assurance Analyst

2 weeks ago

Baltimore, Maryland, United States BioSpace, Inc. Full time
Position Overview


At BioSpace, Inc., we tackle significant public health challenges to enhance and safeguard lives, contributing to a more secure future.

Join a team of dedicated professionals committed to advancing their scientific, technical, and professional expertise to develop products aimed at improving life quality.


I. ROLE SUMMARY

The Senior Quality Assurance Analyst is tasked with overseeing the management of documentation pertinent to the evaluation and approval of Batch Records within the cGMP operations at BioSpace, Inc.

The Quality Assurance Department offers specialized knowledge in problem resolution and process enhancement.

The Analyst will collaborate with various departments to provide essential guidance for maintaining and elevating cGMP compliance across the organization.


II. KEY RESPONSIBILITIES

Reasonable accommodations will be provided to enable individuals with disabilities to fulfill the essential functions.


Batch Record Evaluation and Approval
  • Thoroughly examines GMP documentation, including:
  • Executed batch records across diverse functional areas
  • Analytical Testing Data
  • Microbial and Environmental Monitoring Data
  • WFI testing data
  • Equipment Data
  • Logbooks
  • Conduct SAP Transactions
  • Timely address and respond to client inquiries
  • Facilitate Product Disposition meetings and follow up on outcomes
  • Analyze and disseminate departmental metrics
  • Enter post-release batch data
  • Review documentation and authorize shipments
  • Oversee and file Ancillary forms
  • Scan and archive released batch records
  • Initiate investigations for non-conformance
  • Exhibit strong organizational skills in managing priorities and workload, demonstrating problem-solving abilities both independently and within a team setting.

Quality Operations Support:
  • Compile and report performance metrics related to Batch Review and Release activities.

Continuous Improvement Initiatives
  • Identify areas for enhancement within the scope of responsibilities.
  • Engage in operational excellence initiatives.

Regulatory Compliance Support
  • Provide logistical and technical support during regulatory and internal inspections of BioSpace's quality systems.


The above descriptions are intended to outline the nature of work performed by individuals in this role and are not an exhaustive list of all responsibilities.

Management retains the right to assign or reassign duties and responsibilities to this position at any time, reflecting the essential functions of the role.


III. REQUIRED QUALIFICATIONS
  • Bachelor's degree in Chemistry, Biology, or a related field with 1-3 years of experience in Quality Control or Quality Assurance, or a Master's degree in a relevant discipline with at least 1 year of Quality Assurance experience is preferred.
  • Minimum of 1 year of experience in an FDA-regulated environment is preferred.
  • Strong attention to detail is essential.
  • Ability to manage multiple tasks and priorities in a fast-paced environment.
  • Excellent written and verbal communication skills.
  • Ability to exercise sound judgment in determining appropriate corrective actions.
  • Ability to apply judgment for established practices and policies in selecting methods and techniques for problem-solving.
  • Proficiency in computer applications.
  • Ability to work collaboratively in a team environment.
  • Familiarity with cGMP regulations.
  • Capability to make informed decisions regarding compliance-related matters with moderate supervision.

IV. WORK ENVIRONMENT AND PHYSICAL/MENTAL DEMANDS


BioSpace, Inc. strongly encourages all on-site employees to be vaccinated to ensure their safety and that of their colleagues, adhering to CDC guidelines.

This includes exercising good judgment regarding health and wellness.

There are physical and mental demands, as well as work environment characteristics, that must be met by an individual to successfully perform the essential functions of this role. This information is available upon request.


BioSpace, Inc. is an Equal Opportunity/Affirmative Action Employer and values workforce diversity.

BioSpace does not discriminate based on race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or 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 utilized by BioSpace, Inc. for purposes related to your potential employment.

BioSpace, Inc. respects your privacy, and any use of submitted information will be governed by our Privacy Policy.


BioSpace, Inc. does not accept unsolicited resumes or candidate submissions from search/recruiting agencies not already on BioSpace's approved agency list.

Unsolicited resumes or candidate information submitted to BioSpace, Inc. by search/recruiting agencies not already on BioSpace's approved agency list shall become the property of BioSpace, Inc., and if the candidate is subsequently hired, BioSpace, Inc. shall not owe any fee to the submitting agency.

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