Manufacturing Specialist; Compliance – Grafton, WI

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Manufacturing Specialist, Compliance will be responsible for supporting a wide range of manufacturing quality dependent systems including event investigation, documentation review, and procedure development and maintenance. This position will require the individual to work closely with employees across multiple departments.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities

• Review GMP documents and processes to identify error and provide immediate employee feedback to improve Manufacturing quality performance.

• Perform regular walk throughs of the Manufacturing area to identify and prevent quality events.

• Coordinate and manage timely completion of GMP document corrections.

• Support quality audit activities and responses.

• Support product deviation and failure investigations.

• Identify and implement corrective and preventive actions.

• Track and trend quality events to identify quality improvement opportunities.

• Author, review and approve SOPs required for appropriate manufacturing processing.

• Support SOP training across all shift.

• Flexibility to support a wide range of available working hours in a 24/7 operation.

Qualifications

• High school education or equivalent

• Minimum 3 years’ experience in pharmaceutical manufacturing or quality experience in a cGMP environment

Knowledge, skills and abilities

• Thorough knowledge and understanding of pharmaceutical quality systems

• Excellent communication skills

• Demonstrated technical writing skills

• Strong investigative skills

• Desire to work collaboratively with supporting departments

• Utilize Trackwise, MasterControl, MS Excel, Word and Powerpoint

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia 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, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.