As the Quality Auditor at Sterling, you will perform audit/inspection activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities include, conducting audits and inspections, hosting, and supporting client audits and regulatory inspections, reviewing documents and data, improving programs and process, reporting and improving site KPIs, and maintaining quality databases. The position assists with the development of SOPs or other quality documents as needed, leads and participates in cross function teams and acts as a change champion. At this level an employee will serve as a Lead Auditor for external (supplier) audits.
Essential Functions
Performs internal and external (supplier) quality audits against applicable standards and Sterling requirements.
Perform scoping, risk assessment, planning, execution, reporting of audits and CAPA follow up, where necessary
Take ownership of individual assignments, delivering high quality and timely audit assessments and reports
Performs quality review and approval of documents, data, protocols, and/or reports.
Serves as a Lead Auditor for risk based internal and external (supplier) audits, assuring site compliance to regulations and procedures.
Hosts and/or support client audits and regulatory inspections.
Maintains quality databases, aligning with site needs for metrics and data reporting.
Assists with the implementation and supports quality systems, including but not limited to:
Facilitates and is accountable for ongoing improvements of the internal audit process
Leads and assists with quality improvement initiatives, SOP development and continuous improvement.
Embody our company values, which are: be reliable, be caring, be transparent and be willing.
Key Competencies
Good knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
Good written and oral communication skills as well as presentation skills.
Familiar with basic statistics.
Ability to interact well with vendors, clients, regulatory inspectors, and employees at all levels.
Demonstrated ability as a lead auditor.
Education and Experience
Bachelor's degree in chemistry, Biology, or related field with 8+ years GMP experience or
Master's degree in related field with 5+ years related experience, or equivalent educational and work experience.
ASQ Auditor certification or other cGMP audit certification 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.
