Quality Assurance Specialist

The Quality Assurance (QA) Specialist will play a key role in supporting company's Plant QA organization, providing daily oversight of the Drug Product manufacturing areas in New Albany, OH.

The ideal candidate is a detail oriented QA professional with 2+ years of GMP experience in a regulated manufacturing environment, preferably pharmaceuticals or medical devices, and a strong foundation in QA documentation processes, including change controls, equipment qualifications, and master data approvals.

location: New Albany, Ohio
job type: Contract
salary: $40.00 - 48.57 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Provides on-floor QA oversight of manufacturing operations to ensure adherence to GMP, GDP and company quality standards.
• Review and approve electronic batch records, SOP revisions, work orders, and minor deviations and CAPA records.
• Evaluate compliance issues, provide recommendations, and assure progress of quality records, including Process and Equipment Validation documents through completion.
• Represent QA in the execution of projects necessary to achieve departmental operational goals.

qualifications:

• Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field.
• Two (2)+ years' GMP experience in a regulated manufacturing environment (pharmaceutical, biotech, or medical device).
• Demonstrated knowledge of QA systems, change controls, equipment qualifications, and master data approvals.
• Familiarity with SAP or other EPR systems.
• Proven ability to manage multiple priorities and meet project deadlines with high accuracy and attention to detail.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems
• Strong communication skills (both written and verbal).
• Demonstrated ability to work as both a team player and independently.
• Display leadership attributes and drive improvement initiatives.

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skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice), Quality Assurance (QA)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact ....

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.