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Specialist II, Quality Assurance
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JOB SUMMARY
The Specialist II, Quality Assurance, will support the Supplier Quality Management program for Bora Pharmaceuticals Injectables Inc. Baltimore, MD location. In this role, they will be responsible for day-to-day qualification operations including monitoring suppliers to ensure compliance with established processes, standards, global regulatory requirements, and client specific or other contractual obligations. This position identifies issues that may impact the quality and/or integrity of materials/services procured and works to address these issues. (Telecommuting from anywhere is the U.S. is allowed. Travel up to 75% across the U.S. and internationally to perform supplier audits).
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
The specific duties and responsibilities of this position include:
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Supplier Quality Management (SQM):
- Execute required activities for the qualification and monitoring of suppliers including performance of periodic risk review and risk assessments.
- Evaluate new supplier requests and maintain the Approved Supplier List to ensure supplier information is up-to-date and accurate.
- Develop and manage Annual Supplier Audit Schedule.
- Identify the need for Supplier Quality Agreements, track and initiate their renewal.
- Subject Matter Expert for Veeva SQM module.
- Process and evaluate Supplier Notifications and Supplier Corrective Action Requests (SCARs).
- Follow up with suppliers to ensure implementation of appropriate CAPAs identified through the SCAR process.
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External Supplier Audits:
- Schedule audits, develop audit plans and checklists, and conduct audits.
- Prepare timely, clearly written, concise, accurate, and evidence-based audit reports.
- Clearly communicate audit findings and compliance risks to Management, internal stakeholders and/or the supplier.
- Follow audits to completion.
- Review and evaluate audit responses.
- Maintain audit information in a thorough and accurate manner.
- Own, approve, and participate in CAPAs, deviations, and change controls related to the above functions, as needed.
- Aid in the establishment and maintenance of policies and procedures for the Supplier Quality Management program by collaborating with team members and other internal stakeholders.
- Support other activities within the QA department by serving as a Supplier Quality Subject Matter Expert, which may include providing compliance metrics for site/corporate management, supporting regulatory inspections, internal audits, client audits, annual product reports and other quality or regulatory activities as needed.
- Resolve a wide range of issues in creative ways. Defines appropriate actions and requirements for resolution of issues.
- Demonstrate clear understanding of related SOPs, cGMPs and regulations necessary to accomplish daily tasks.
- 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
EDUCATION
- The position requires a Bachelor’s degree in Chemistry, Biology, Chemical Engineering, Pharmaceutical Engineering/Management or a closely related scientific technical field.
EXPERIENCE:
- At least 7 years of progressively responsible quality assurance experience in the biopharmaceuticals industry, including: working with CGMP, Supplier Quality Management (including evaluation of new supplier requests, supplier notifications, and supplier complaints), Risk Assessments, Quality Systems integration/implementation, Data Integrity, and Batch Review; authoring, reviewing and assessing Deviations, CAPAs, and Change Controls; and preparing GXP audit plans/schedules and reports, SOPs, Work Instructions, and Quality Agreements.
- Experience should include at least 4 years of managing supplier audits as a lead auditor and overseeing compliance with domestic and international regulations, including US FDA, Health Canada, and EMA in drugs.
- Minimum of 2 years of quality assurance experience in sterile fill/finish required.
- 2 years of experience working with the Veeva SQM module. Experience can be gained concurrently.
SKILLS
Must have ASQ CQA certification.
Salary: $131,976/year. Please apply at or send your resume for consideration directly to . Include Specialist II, Quality Assurance in the subject line for email communication.
Compensation Range:
$100,851.00 - $151,276.00
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
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