Specialist II, QA Complaints

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Description:

Job Title: Specialist II, QA Complaints

Location: Columbus, Ohio

Job Type: Full time

Req : 12231

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Specialist II, QA Complaints to join our team.

In this role, you will be responsible for ensuring quality and compliance to regulations with respect to investigation of atypical events, i.e. Investigate and document atypical events – resulting in a recommendation of final disposition for goods, while identifying appropriate Corrective Action-Preventative Action (CAPA).

Conducts investigations on atypical events and documents accordingly to meet a Code of Federal Regulations requirement:

• Locates the batch record
• Interviews the people involved with the process in question
• Documents all facts in the investigation form
• Determine the root cause of atypical event and CAPA
• Makes recommendations

Conducts meetings to discuss findings and obtain resolution/commitments from customers. Ensures agreement on investigation findings and appropriate CAPA has been identified with appropriate department.

• Emails investigation form to possible involved personnel to ensure all required people are involved
• Schedules meetings with appropriate personnel

Works directly with peer customers to resolve issues

• Gather and document factual data that is used in written investigations to justify disposition of material
• Interviews employee and asks questions about incident report

Recommends corrective actions as part of the atypical events investigation and follows up/becomes involved with department to provide guidance

• Appropriate CAPA will help eliminate/minimize recurrence of atypical events
• Sets up meeting with all affected departments
• Determines appropriate CAPA

Makes recommendations with assistance of supervisor related to go/no-go decisions which impact production.

• Keeps production moving with timely responses. Consult with supervisor to ensure knowledge is passed on, up and down the chain.
• Assesses situation to determine if production should be continued or interrupted after an atypical event
• Contacts managers to ensure all information is passed up and down the chain

Coaches and trains others on basic quality investigations for procedures and basic regulations

• Ensure all parties involved understand why we have to do what we do
• Conducts peer reviews of others investigator’s work
• Answers any questions and directs fellow investigators

Writes/revises Quality Assurance Departmental Procedures, Standard Operating Procedures, and documentation to ensure compliance to requirements and efficient standardize practices.

• Goes out on floor and researches step-by-step walkthrough of process
• Conducts mock implementation
• Recommends changes to procedures after investigations

Communicates clearly to peers, customers, and supervision. Communication is key to identifying root cause of the atypical event and appropriate CAPA

• Communication imperative so that all operating units understand impact of atypical event at all stages of the investigation

Other duties as assigned

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• High school diploma or GED required,…