Quality Engineer I - Sterling Pharma Solutions
Sterling Pharma Solutions

Job Info

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Summary of Role
The Quality Engineer I is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, participating in inspections/audits, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position requires strong demonstrated behaviours of the Sterling core competencies of transparency, willingness, reliability and caring and non-negotiables, as well as expertise in functional competencies included in this position profile.

Your Responsibilities

• Performs quality review and approval of documents, specifications, all types of data, protocols, and reports.
• Maintains quality databases and performs monitoring and/or analysis of process data to drive quality improvements.
• Assists with quality improvement initiatives as needed by working collaboratively with different departments to identify, develop, and implement appropriate controls and when applicable corrective actions.
• Coordinate development/writing/review of SOPs, work instructions, equipment and software Installation (IQ), Operational (OQ) and Performance (PQ) Qualifications or other quality documents and/or reports as needed.
• Provides consultation on quality and compliance topics in areas of expertise of process validations, statistical analysis, statistical process controls to ensure workflows, processes, and product comply with regulations and SOPs.
• Develop and/or review risk management, design control, quality procedures, and engineering plans.
• Performs duties related to documentation and follow up to Corrective / Preventative Actions (CAPA) and Change Control plans to ensure timely completion of actions.
• Serves as an effective member of the Quality team and may serve as a mentor to other Quality employees in the area of expertise.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Requirements for the Role

• Bachelor's degree in Engineering or related technical field with 3+ years GMP related experience, or Master's degree in related field with 2+ year related experience, or equivalent educational and work experience.
• ASQ Certified Quality Engineer (CQE) or comparable preferred
• Knowledge in statistical analysis is preferred.

What We Offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.

Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.

Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent. Be willing. Be reliable.

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