Sr. Specialist, Quality

Job Description

Senior Specialist, Quality Assurance

The Quality Assurance team ensures that every material used in our products is manufactured, tested, packaged, stored, and distributed according to high standards of quality and in compliance with all regulatory requirements.  The Senior Specialist, Quality Assurance will support ongoing efforts to supply the market by providing quality oversight for Validation, Plant Engineering, and Deviation Management activities related to drug substance and drug product manufacturing.

Position Responsibilities

Reporting to the Associate Director, Technical QA, the Senior Specialist, QA Technical will independently manage assignments related to compliance with cGMP regulations and our Company’s Quality Management System. Responsibilities include:

• Supporting Validation, (Re)qualification, Deviation Management, and compliance activities of equipment used in manufacturing areas.

• Reviewing and approving technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports related to the assigned area.

• Partnering with site functions to solve problems and achieve goals.

• Collaborating closely with the Technical Operations team to track and complete assignments related to equipment validation/qualification and deviations.

• Making decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.

• Escalating and consulting with the next level manager on more complex decisions as needed.

Position Qualifications

Education Minimum Requirement

• Bachelor’s Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or a related life science or engineering discipline.

Required Experience and Skills

• With a Bachelor’s Degree: At least 5 years of experience in the pharmaceutical industry or a different highly regulated industry.

• With a Master’s (or other advanced) degree: At least 3 years of experience in the pharmaceutical industry or a different highly regulated industry.

• At least 1 year of experience in aseptic manufacturing or another cleanroom environment.

• Strong contemporary knowledge of relevant current Good Manufacturing Practices (cGMPs), regulations, and current industry trends.

• Effective decision-making, problem-solving, and communication skills.

• Ability to manage multiple priorities.

• Demonstrated ability to work in fast-paced, complex environments and escalate issues appropriately.

• Experience with the development, review, and approval of validation/qualification documents and investigations related to pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities.

Preferred Experience and Skills

• Prior experience in change control and deviation management.

• GMP quality experience with biological drug substances or drug products.

• GMP experience with validation/qualification of equipment.

• Experience with Quality Risk Management.

• Project management experience in a highly regulated industry.

• Familiarity with Kneat, SAP, Veeva, MEDS, and GLIMS.

• Experience in deviation management with a focus on quality review and approval.

• Experience in aseptic processing, aseptic observations, and techniques.

• Participation in regulatory inspections.

• Conversant with all domestic and foreign regulations and compendia governing plant operations.

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, pro