Quality Specialist - Pharmaceutical Manufacturing

Yoh
US - Indiana - Noblesville
October 18, 2024
Engineering

Yoh is seeking a Quality Supplier Specialist for our Pharmaceutical client in Noblesville, Indiana.

Industry: Pharmaceutical
Salary: $30-$34/hr
Location: Noblesville, IN
Type: 6 month contract

This role is responsible for supporting the Supplier Quality Specialist organization through the site's Supplier Quality program meets applicable GMP regulations. This role certifies new suppliers, conducts re-assessments, authors SCAR investigations, authors vendor change controls and may conduct supplier audits.

Essential Functions
Maintain the certified supplier list.
Ensure the site supplier assessments are current and up to date based on quality risk.
Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Serve as site auditor for suppliers and ensures adherence to supplier schedule.
Authors and owns supplier change control (notifications) process.
Submits SCAR deviations to suppliers for defects found.
Provide support for FDA or other regulatory agencies for on-site audits.
Serve as site Quality SME on MSD.

Requirements
Bachelor of Science in Biology, Chemistry or related field required.
3 or more years of relevant pharmaceutical indsutry experience required.
Supplier Quality experience Experience with doing vendor evaluations, sending questionnaires
Doing risk evaluations, handling supplier complaints

Experience investigating exceptions and out of specifications preferred.
Must be able to resolve problems, handle conflict and make effective decisions under pressure Root Cause Analysis.
Must be proficient in use of Microsoft suite office products; good computer skills, including utilizing personal computers and data entry programs.
Good hands on, analytical, and problem solving and decision-making skills.
Excellent writing and verbal communications skills.
Ability to work independently and with others to accomplish goals and priorities.
High level of energy and regular, consistent attendance.
Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment.

The Individual
Needs to be amiable Get along with a small group
This is an outward facing role, so they will be interfacing internally & externally Needs to have a level of professionalism

Needs to be able to see an issue & knows what needs to be done to correct it
Action oriented drives for results
Needs to have good interpersonal skills Speak to different individuals on all levels

Be willing to travel (in & around Noblesville) If able to do supplier audits may be asked to travel (throughout the US to different suppliers)

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, 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, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Read the full job description and apply online on the recuiter's web-site

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