Sr. In-Process Quality Engineer

About the Role

Acts as the Quality Assurance subject matter expert for assigned Quality Systems and product lines. This includes involvement in systems, procedures, investigations and manufacturing (current Good Manufacturing Practices) cGMP compliance as both a participant and a facilitator. This position is responsible for identification and implementation of continuous system improvements, oversight of critical quality systems as assigned and disposition of pharmaceutical products.

Responsibilities

• Evaluates, updates and approves existing SOPs for cGMP compliance and compliance to corporate procedures
• Oversees and participates in the Change Control process including the writing, review and approval of Change Controls
• Oversees and participates in the CAPA process, including writing, review, and monitoring of action items
• Works with the appropriate discipline to identify change actions or corrective/preventative measures necessary for improvement and to align processes to consistently manufacture quality products
• Leads and participates in Process Improvement teams
• Performs trending of Quality Systems including but not limited to: Exceptions, CAPA, Change Control, Annual Product Review, Supplier Quality, and Internal and External Audits
• Champions a Quality System, monitoring user activity, due dates, extensions, and content approval
• Independently leads gap assessments and remediation efforts
• Provides technical expertise and guidance to other team members
• Identifies and mitigates risks of current practices to process, product and patient
• Writes, reviews and approves Exceptions in EQMS
• Reviews and Approves Out of Specification Investigations in EQMS
• Works with individuals performing investigations to ensure the process is handled with the appropriate level of detail
• Leads and participates in Root Cause Analysis teams
• Reviews and approves investigation reports to ensure it contains the appropriate level of detail and appropriate CAPA's are identified
• Reviews investigations and uses process and equipment knowledge, subject matter expert input, technical documents, and risk management tools to determine potential product impact and product disposition
• Assists in the compilation of eCTD submission documentation (NDA/ANDA original submissions, supplemental applications, annual report compilation packets)
• Assists in the compilation of international dossier documentation
• Participates on product and process development/transfer teams as assigned
• Provides technical expertise and guidance in the generation of Regulatory Strategy requests
• Generates Annual Product Reviews / Annual Product Risk Assessment report
• Supports internal and external audits and inspections

Qualifications

• Bachelor Degree in engineering discipline or technical field related to pharmaceutical manufacturing is preferred or Associates Degree with equivalent combination of education, experience, and competencies accepted
• Minimum of 5 years of technical experience in a pharmaceutical manufacturing environment (including QA/QC or engineering experience)

Preferred Skills

• Strong verbal and written communication skills
• Knowledge of Quality Systems
• Knowledge of cGMPs for Finished Dosage Products
• Understanding of basic statistical principles, basic knowledge of validation principles, techniques, and regulatory experience
• Ability to quickly identify, communicate and/or resolve issues
• Effective communication and leadership skills

Skills

• Strong computer literacy—MS office products, statistical analysis (Minitab) and database usage

Pay

The expected base pay range for this position is $100,000 – $135,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

Schedule

Availability to travel at least 10-20% time is required for this position.