Specialist I, Quality Operations

Bora Pharmaceuticals; Baltimore (MD); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive health coverage

Retirement savings plan

Paid time off

Professional development

Wellness programs

Employee assistance program

Job summary

Bora Pharmaceuticals is seeking a Quality Assurance professional to provide technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities. The role includes leading investigations and root cause analysis, assessing risk, and supporting change controls and technology transfers.

The position requires strong cGMP knowledge, experience with CAPA programs, and solid technical writing skills.

Qualifications

• Bachelor’s degree in a technical field and 5–7 years in pharma or CDMO settings.
• Experience leading deviations, investigations, OOS/OOT events, and non-conformances.
• Experience implementing corrective/preventive actions and change controls.
• Knowledge of process validation, equipment qualification, and CPPs.
• Ability to analyze process and product data with statistical tools and trends.

Responsibilities

• Provide technical quality oversight for manufacturing processes, products, equipment, facilities, and client programs.
• Lead investigations of deviations, complaints, OOS/OOT, and non-conformances using root cause tools.
• Develop and monitor CAPAs to ensure timely closure and sustained effectiveness.
• Perform risk assessments, gap analyses, and impact assessments for changes.
• Review validation, qualification, stability, and process verification docs.
• Support change controls, tech transfers, and new product introductions.

Skills

Root cause analysis

Change control

Deviation investigations

cGMP knowledge

Technical writing

Data analysis

Education

Bachelor's degree in engineering, pharmaceutical science, life sciences, or technical discipline

Tools

Statistical tools

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary

This position provides technical quality support for manufacturing processes, equipment, facilities, and product lifecycle activities within the Quality Assurance Department. Primary responsibilities include leading investigations and root cause analysis, assessing process and product risk, reviewing validation and qualification documentation, analyzing performance trends, supporting change controls and technology transfers, and developing sustainable corrective actions and process improvements. The role helps ensure compliant, capable, and reliable operations. This position is on-site, full-time.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Provides technical quality oversight and support for assigned manufacturing processes, products, equipment, facilities, and client programs.
• Partners with cross-departmentally to resolve complex quality and compliance issues.
• Leads or supports assigned investigations of deviations, complaints, PAs, OOS, OOT, and other non-conformances using structured root cause analysis tools.
• Helps develop, evaluate, and monitor corrective and preventive actions to ensure timely completion and sustained effectiveness.
• Performs quality risk assessments, impact assessments, and gap analyses for processes, products, equipment, facilities, and proposed changes.
• Reviews and approves protocols, reports, specifications, procedures, and technical documentation associated with validation, qualification, stability, and continued process verification activities.
• Evaluates process capability, product performance, and quality-system data; identifies adverse trends and recommends appropriate actions.
• Applies statistical and analytical tools to support investigations, trend analysis, risk-based decisions, and process improvement.
• Provides quality expertise and insight for change controls, process changes, equipment or facility modifications, technology transfers, and new product introductions.
• Identifies opportunities to improve process robustness, reliability, compliance, and operational efficiency and supports implementation of approved improvements.
• Supports annual product reviews, regulatory submissions, client responses, inspections, and audits by providing technical assessments and quality documentation.
• Serves as a technical quality resource for cross-functional teams and communicates risks, recommendations, and decisions clearly to stakeholders.
• Supports the development and maintenance of quality metrics, dashboards, and management-review inputs.
• Maintains current knowledge of cGMP requirements, applicable regulations, industry standards, and site procedures.
• This position may be trained using Virtual Reality and/or AI.

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 management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Skills and Experience

• Bachelor's degree in engineering, pharmaceutical science, life sciences, or technical discipline.
• 5-7 years of experience supporting pharmaceutical, biologics, or other regulated manufacturing operations; CDMO experience or sterile finished required.
• Demonstrated experience leading or supporting deviations, investigations, OOS/OOT events, complaints, and other non-conformances using structured root cause analysis methods.
• Experience developing, implementing, and assessing the effectiveness of corrective and preventive actions.
• Working knowledge of process validation, equipment and facility qualification, change control, technology transfer, and continued process verification.
• Demonstrated ability to analyze process and product data using statistical tools, identify trends, and translate findings into risk-based recommendations.
• Ability to evaluate process capability, product performance, and quality-system effectiveness and recommend sustainable improvements.
• Strong technical writing skills with experience reviewing and authoring investigations, protocols, reports, risk assessments, procedures, specifications, and regulatory or client-facing documentation.
• Advanced knowledge of cGMP requirements, applicable FDA and EU regulations, ISO standards, and other relevant industry guidance.

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals 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 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.