Quality Assurance Specialist - Yoh : Job Details

Yoh is hiring a QA Specialist for our Pharmaceutical client in Noblesville, Indiana. This is a great opportunity to join a growing facility. Location: Noblesville, IN (onsite)Pay: $35-$40/hr.Hours: M-F 8 am - 4:30 pmType: 6 month ContractSummary of Position:Quality Assurance Specialist position is responsible for technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. This position will generate and revise procedures, forms, etc., and support the quality assurance team as needed. This position reports to the Senior Director of Quality. Day to Day:

• Review and edit documents for accuracy, completeness, and consistency.
• Track document status and manage document revisions and updates.
• Perform QA on the Floor function.
• Gown into a grade C and D environment.
• Monitor aseptic operations for Quality Assurance.
• Review batch record completeness for accuracy and compliance.
• Manage and prioritize projects in an organized and structured manner.
• Create, review, and approve Quality policies and procedures.
• Initiate, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).
• Support regulatory and client audits.
• Conducts internal audits of the QMS and sub systems.
• Analyze data to identify areas for improvement in the quality system.
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor Degree in Science or related field required.
• Minimum of three years of experience in a Pharmaceutical or Medical Device Quality Systems/Quality Assurance
• Knowledge of tools, concepts and methodologies of Quality.
• Auditing experience, along with deviation and lot release support.
• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer Systems
• Working knowledge of cGMP guidelines.
• Proficient in use of Microsoft suite of products.

#IND-SPGNote: 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.