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Quality Assurance Specialist

  • Permanent
  • Anywhere

Website J. Knipper and Company, Inc.

J. Knipper and Company, Inc.

Company : J. Knipper and Company, Inc.

Country: United States

Location : Charlestown, Indiana

Post: Sun, 19 Sep 2021 14:54:36 GMT

Expires: Sun, 17 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Overview:
Founded in 1986, J. Knipper and Company, Inc. and its affiliates, KnippeRx and Eagle Pharmacy, are dedicated to providing services exclusively for the pharmaceutical and life sciences industries. We are in an exciting accelerated growth phase fueled by our three integrated business units; Third-Party Logistics (3PL), Custom Pharmacy Solutions (CPS), and Marketing Support and Samples Management (MSSM).  Our company’s focus and mission are based on building partnerships and collaborating with our clients to create solutions that are strategically designed, faithfully executed and driven by market insight and data to ensure maximum return on our clients’ investment, ultimately improving people’s lives. The Knipper Vision: Create the shortest path between patient and therapy.

 

Join the growing Knipper family today!

The Quality Assurance Specialist is responsible for serving as one of the administrators of Knipper’s quality management system (e-QMS) and back-up to the supervising CAPA Manager or QA Manager; independently conducting audits and investigations. The QA Specialist – Auditing will prepare, conduct, gather audit evidence, write audit reports and monitor corrective action activities through completion.   The QA Specialist – Auditing will adhere to the internal and vendor audit schedule as developed by Regulatory affairs and QA on an annual basis.   The QA Specialist – Auditing will perform inspections routinely as required by QA Management and will support client audits when required. The QA Specialist will support the CPS, MSSM and 3PL business units by investigating incidents and quality events to determine the root cause. The QA Specialist will track the progress and completion of corrective action plans implemented as a result of the investigation of incidents and quality events. The QA Specialist will provide investigation reports to Management, as requested.

Responsibilities:
For approximately 6-9 months, the hired contributor will assist the team with leading and conducting destructions within our distribution center for 60% of their day.

Prepare, perform, close and report on audits conducted.

Provide auditee with analysis appraisal, recommendations, counsel and information concerning the activities audited.

Evaluate auditee’s processes for compliance with quality requirements.

Assist in the development of audits plans and audit schedules.

Participate / lead quality audits as required.

Identify processes, situations, etc. where the auditee is meeting requirements as well as identify opportunities for improvement.

Conduct / assist with follow-up audits as required.

Conduct Quality investigations of incidents and Quality Events to support the CPS, MSSM and 3PL business units and ensure the completion of CAPAs and effectiveness checks occur in a consistent compliant and timely manner.

Collaborate with each business unit to resolve incidents and Quality Events using business communications, trending, root cause analysis, and corrective/preventive action activities to allow the business to improve product and process quality.

Document the results of the investigation results in the appropriate system.

Qualifications:
Bachelor’s Degree

Experience in pharmacy operations, pharmaceuticals or related field

1-2 years of prior auditing experience

Certification by recognized authority to conduct audits preferred

Pharmacy Technician license or registration preferred

Regulated industry experience preferred

Ability to work independently and in a team environment

Very good communication and writing skills and customer service or auditing experience.

Ability to prioritize multiple tasks and accomplish them in a timely manner.

Proficient in Microsoft Office applications. WORD Level – basic skills required; EXCEL – Intermediate Level required.  Ability to learn internal software programs including eQMS/TrackWise, PrimeRx, SharePoint, TimeTrak, SCALE (WMS) and Promail.

Ability to maintain the highest level of confidentiality.

Knowledge of Quality Assurance Systems

Strong knowledge of cGMP and Good Documentation Practices

Ability to use a calculator to perform basic math functions and understands the concept of same including: add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals; compute ratio, rate and percent.

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