Senior Quality Engineer

APHENA PHARMA SOLUTIONS-MARYLAND LLC; Easton (MD); On-site; USD 85,000 - 125,000; Full time

Job summary

APHENA PHARMA SOLUTIONS-MARYLAND LLC seeks a Quality Engineer to oversee and support all phases of the product quality lifecycle as we transfer products into commercial operations. You will drive tech transfer with cross-functional teams and ensure on-spec production and continual improvement.

The role includes collaborating with site leadership to analyze incoming materials, drive CAPA, and maintain quality documentation to support manufacturing and packaging operations.

Qualifications

• 5+ years in an FDA-regulated industry (medical device/pharma).
• Experience with root-cause analysis and CAPA processes.
• Strong technical writing and data analysis skills.

Responsibilities

• Drive tech transfer activities across the product lifecycle.
• Support quality operations during commercialization and scale-up.
• Trend quality data and investigate deviations/complaints.
• Prepare and review MSA, Control Plans and related docs.
• Collaborate with suppliers and cross-functional teams to ensure compliance.

Skills

Quality engineering

Root cause analysis

Data analysis

MS Office

Statistical software

Cross-functional collaboration

Education

Bachelor's degree in engineering or related science

Tools

ERP systems

eQMS

Documentation tools

Job description

Job Details: Job Location: Liquid and Topicals Division MD - Easton, MD 21601, Position Type: Full Time, Education Level: 4 Year Degree, Job Category: QA - Quality Control, Job Summary:

The Quality Engineer is a key, customer-facing role that will be responsible for or support all phases of the product quality lifecycle of the customer program, as the product transfers into commercial operations. The QE will ensure a successful tech transfer with NPI by directly supporting or driving the tech transfer processes with appropriate cross-functional teams.

As the new product is fully scaled into commercial operations, the QE will be responsible or support all phases of quality operations, ensuring the product is produced according to the established product specifications, and driving continual improvement to ensure ongoing standardization, simplification, and optimization of the product manufacturing packaging processes.

As a key part of the Quality Team, the QE will work directly with the site leadership and operational teams to assess, analyze, and trend quality of incoming materials (lot to lot variation) to ensure reduction of variation in the product manufacturing process. The QE will be responsible for identifying and containing non-conforming products and driving root cause during investigations, with appropriate CAPA to prevent reoccurrence.

The QE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed.

Essential Functions:

Technical (Product and Process)

• Drive and support new customer programs throughout the product lifecycle and deliver on the customer experience and program management
• Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.
• Develop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams for FMEA, into sustainable engineering and commercial operations.
• Trend manufacturing data and contract service providers results.
• Assistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation, and the subsequent revision of documents.
• Drive root cause analysis of deviations/complaints.
• Support project teams through the selection of correct manufacturing concepts and fundamental technology to ensure successful project outcomes.
• Develop work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.
• Identify opportunities and develop recommendations to improve products and processes.
• Interpret product requirements and develop concepts, components, and products in compliance with applicable quality system procedures, industry, and business standards.
• Supports the generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements.
• Maintain QE process discipline to achieve project deliverables, including but not limited to, supporting manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, supporting cost modeling, and process validation/qualification.
• Employ data driven tools and methodologies to implement structured and timely problems.
• Development and/or review of technical specifications and Protocols (IQ/OQ/PQ, etc.).
• Participate in External Audits of Suppliers/Contract Service Providers.
• Track and trend raw material and key components to measure variation and part quality over time, in order to drive appropriate and timely improvement with key suppliers.
• Participate in required training events.
• Any and all other duties as assigned.

Leadership

• Collaborate with the engineering, commercial operations, procurement and ancillary groups and wider development, manufacturing, and procurement teams for high-priority product-program initiatives.
• Attention to detail and self-motivation to deliver work to the highest standards.
• Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.
• Timely problem-solving using data driven tools and methods.
• Presentation of quality standards, process flows, inspection plans and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.

Other - General

• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Quality Director. May assist in the areas of NPI as needed.
• Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.
• Knowledge of and adherence to all Aphena, cGMP, GAMP, 21CFR Part 820, 21CFR Part 11, 21CFR Part 211, ISO9001, ISO13485, procedures, rules, and requirements.

Qualifications: Qualifications

• College Degree required (engineering degree or related scientific degree preferred). Must have a minimum of at least 5+ years of experience in an FDA regulated industry with strong preference to medical device, pharmaceutical, or drug device combination products.
• Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (statistical, ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
• Prior experience in technical writing and utilizing root cause analysis tools is required.
• Critical thinking skills along with a strong collaborative approach is required.
• Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.

Preferred

• Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.
• Technical knowledge and experience with Medical Devices and Pharmaceuticals, in a CDMO or CMO environment, is highly desirable.