Quality Assurance Specialist (GMP TrackWise Experience Preferred)
Quality Assurance Specialist (GMP TrackWise Experience Preferred)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
Client is seeking a temporary Quality Management Systems Specialist to join our dynamic Quality Assurance team at our Greendale Indiana site. This role is critical to the integrity and continuous improvement of our sites Quality Systems and will be responsible for supporting key compliance and quality system activities such as entry of Change Controls Deviations Complaints and CAPAs into TrackWise. The ideal candidate will bring an understanding of GMP principles experience in pharmaceutical or dietary supplement manufacturing and basic user knowledge of electronic quality systems (i.e. TrackWise or similar).
II. Specific Tasks Duties and Responsibilities:
Responsibilities include but are not limited to:
Quality Systems Oversight
Support site-level quality systems such as: Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
Ensure timely and thorough completion of assigned documentation tasks.
Support cross-functional teams quality system updates.
Computerized System Compliance
Support Data Integrity initiatives for electronic systems including TrackWise EDMS and other validated platforms.
Participate in system upgrades validation activities and periodic reviews to ensure ongoing compliance.
Documentation & Audit Support
Collaborate with Document Control and QA teams to ensure controlled documents are accurate current and compliant.
Support internal client and regulatory audits by preparing documentation as assigned.
Assist in batch record review/filing complaint investigation initiation and audit readiness activities as needed.
III. Essential Skills Experience Qualifications:
Required:
2 years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred).
Experience with 21 CFR 111 21 CFR 211 or 21 CFR 11.
Working knowledge of Quality Systems and Quality Assurance
Experience with Microsoft Office Suite.
Excellent written and verbal communication skills.
Strong organizational and time management abilities.
Preferred:
Experience with TrackWise and/or EDMS or equivalent
Lean Six Sigma or similar continuous improvement training
Project Management
Employment Type
CONTRACT
