Job Description:

The Sr. Quality Engineer works under minimal supervision to provide quality assurance support in accordance with regulatory requirements as it relates to biologic therapeutics and compliance with cGMP, relevant ICH and Global regulations. This role will support the execution of medium complexity projects that will impact the Quality of the product significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management, process improvement, CAPA, internal audits and quality system improvements.

Responsibilities:

• Support supplier management process which may include supplier qualification, audits, SCARs, reviewing and providing input to Quality Technical Agreements and on-going supplier monitoring.
• Manage suppliers of materials, parts, and services through a risk- based approach.
• Perform and support internal and external audits.
• Interface and collaborate with internal departments and external regulatory bodies regarding compliance needs as required
• Support review and approve Complaint, CAPA, Audit Findings, Deviation investigations to provide guidance to ensure effective investigations are completed.
• Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
• Participate in third party (Notified Body, FDA,) audits as required.
• Supports high-risk investigations to document Quality Issues resolutions within a CAPA, SCAR, Deviation, Audit finding to ensure proper and robust actions are taken to eliminate re-occurrence.
• May guide, coach, and train other personnel on topics such as auditing, Root Cause Analysis, CAPA, deviations, etc.
• Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
• Ensure Site Metrics are complying with internal requirements and goals established.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Contributes to continuous process improvement efforts, improve efficiency, quality culture reinforcement, and eliminate waste.
• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Performs other duties as assigned based on business needs.

Requirements:

• Bachelor's degree in science, (chemistry, microbiology or biotechnology) with microbiology preferred.
• Minimum 7 years' experience in GMP Quality roles.
• Minimum 3 years' experience in pharmaceutical industry.
• Demonstrated experience in problem solving, root cause analysis and risk management methods.
• High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, and Excel.
• Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.
• Effective technical writing skills and ability to understand quality requirements as they relate to supplier negotiations and quality agreements.
• Certified auditor preferred.
• Certified Quality Engineer preferred.
• Experience in computer system validation requirements is a plus
• Experience in Veeva, SAP, and/or Trackwise is a plus

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $93,818 to $174,233, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

Location:
Roseville, Minnesota