Quality Engineer - Direct Hire

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

The Quality Engineer will focus on the company's quality standards, manufacturing processes and testing systems to reflect efficiency, reliability and the highest quality performance. The Quality Engineer must be familiar with applicable cGMP regulations and systems and can make decisions based those requirements. This individual will be responsible for providing Quality Engineering guidance through validation of manufacturing processes, recommendation and implementation of process improvements, quality data analysis, and employing effective corrective actions for continuous improvement solutions. The Quality Engineer will report to the Manager of Quality Assurance.

Primary Responsibilities

• Write and execute process validation studies (e.g., product, cleaning, sterilization, media fills).
• Establish Standard Operating Procedures.
• Perform investigation of product nonconformances, conduct root cause analysis in accordance with internal procedures.
• Create, generate, analyze, and report quality metrics throughout all levels of the organization to drive continuous improvement by using statistical tool methodology. In addition, must demonstrate the ability to apply statistical tools to define sampling strategies (i.e. six-sigma, etc.).
• Assist in training and maintenance of the site Quality Management Systems.
• Audit critical manufacturing processes to ensure cGMP compliance and approve critical manufacturing areas for use.
• Change of in process status of drug product and materials.
• Assist in product recalls.
• Performs tasks/deviations/investigations/protocols/CAPAs of moderate and high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions. Responsible the timely closure of investigations.
• Partner with cross-functional team members to address and resolve quality issues; ensure appropriate training, processes and equipment are in place for all manufactured products.
• Write/execute/review/approve risk assessment and quality protocols.
• Plan, review, and approve change requests.
• Review/Approve Master Batch Production Records.
• Assist in the preparation of inspections/audits performed by regulatory agencies.
• Assist with FDA regulatory inspections.
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
• Experience working with cross-functional groups such as planning, manufacturing, packaging, and distribution to ensure proper priorities are set and necessary activities are planned to meet these goals.
• Other duties as assigned.

Experience and Education

• Minimum of 3 years of applicable industry (quality, manufacturing, validation) experience in an aseptically fill/finish operations preferred, FDA regulated manufacturing environment - cGMP pharma experience required.
• Bachelor's degree in a science, engineering or business discipline coupled with relevant work experienced is required.
• Previous experience with review of quality related documentation and batch documentation required for regulatory submissions highly desire.
• Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized.
• Computer literate, ability to work with MS Office and software programs related to the position.
• Ability to perform basic statistics, understanding of AQL sampling plans and basic formulation calculations.

Travel Requirements

• 5-10% Travel required for this role.

Physical Demands

• Lifting requirements are no more than 25 pounds.
• Standing for long periods of time and walking through the facility.
• Ability to self-gown and de-gown oneself from the manufacturing area.
• Works with chemicals and wears basic personal protective equipment (PPE) (glasses, gloves, ear protection), and restrictive PPE (Tyvek suits, respirators).
• Manufacturing and office environment.

Mental Demands

• Ability to read, understand and follow instructions written in English in SOPs, batch records, cGMPs, etc.
• Required to exercise good judgement as errors may cause moderately serious delays, confusion and could affect company reputation and/or customer relations.
• Multi-tasking and prioritization skills.

Level of Proficiency

• Must be able to work independently.
• Strong organizational skills.
• Must effectively work with different departments and communicate with all levels of management.

Schedule

• First shift
• 8-hour minimum
• Onsite

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

USDM Life Sciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.