Purpose and Scope
The Quality Engineer supports Quality Assurance by analyzing data and identifying trends in product/process data that can affect product quality. This is accomplished through authoring Annual Product Reviews (APRs), identifying and leading process improvements projects, and providing statistical analysis to enable quality decisions.
Essential Duties & Responsibilities
Review current quality issues and identify ideas for process improvements on any Quality Systems.
Develop project plans and lead cross-functional teams through execution to completion.
Lead and facilitate continuous improvement projects for quality systems.
Develop and complete Annual Product Reviews in a timely manner in compliance with regulatory requirements for contents, trends, and approvals.
Responsible for developing procedures and compliance related to APRs, Statistical Analysis, yield calculations, Risk Assessments and Failure Modes and Effects Analyses (FMEAs).
Compile and evaluate data for Quality Management Review presentations.
Provide guidance and statistical evaluation to interpret analytical data associated with product release, stability reports, validation activities, laboratory investigations and manufacturing investigations to support Tolmar release and compliance decisions.
Participate in decision-making process regarding product quality issues.
Provide statistical support and Design of Experiments (DOE) for internal investigations, validations and any Quality System continuous improvement action plan.
Define, identify and apply product and process control methods such as developing control plans and identifying critical control points for sampling/inspection.
Develop a variety of quality reports and provide tracking and trending data for proactive resolutions and evaluation of product performance per established regulations such as Stage 3, Continued Verification Process.
Serve as a QA representative on project teams to define critical points and classify product defects.
Interact with investigators/ auditors during regulatory inspections and marketing partner audits.
Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
Perform various other duties as assigned.
Knowledge, Skills & Abilities
Proficient knowledge with statistical software packages and MS Office.
Excellent verbal and written communication skills demonstrated through interactions internally and externally.
Ability to independently lead cross-functional teams in support of continuous improvement projects.
Ability to work both independently and in conjunction with a team.
Ability to develop working relationships with both internal and external customers.
Effective organization and project management skills.
Effective troubleshooting and problem solving skills.
SME in statistics and statistical software (Minitab or JMP preferred).
Strong working experience in tracking and trending of data.
Strong working experience with control charts, process capability and presenting information.
Six Sigma tools experience (Black or Green belts) strongly preferred.
Experience with Injectable dosages preferred.
Knowledge of FMEA methods and process.
The Quality Engineer is expected to operate within the framework of Tolmar’s Core Values:
Consistently operate with the highest standards of ethics and compliance.
Take ownership of your actions, success and setbacks.
Respect each other and understand that honest collaboration is at the heart of our company success.
Go the extra mile to make things happen.
Be committed to all we do and the patients we serve.
Embrace change with enthusiasm.
Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
Education & Experience
Bachelor’s degree in Chemistry, Engineering, Biology or other related field required.
Five or more years of Quality Engineering/Quality Assurance experience in a pharmaceutical, medical device or manufacturing industry required.
CSSGB, CSSBB and/or CQE preferred.
Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work.
Occasional work inside manufacturing clean rooms where gowning is required.
5 year(s): Quality Engineering / Quality Assurance experience in a pharmaceutical, medical device or manufacturing industry.
CSSGB, CSSBB and/or CQE
Bachelors or better in Engineering or related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)