Specialist II, QA Complaints

Job Title:      Specialist II, QA Complaints

Location:      Columbus, Ohio

Job Type:      Full time

Req ID:          12231

About Us: 

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.

Description:

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).

Key Responsibilities:

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

Qualifications:

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, along with 3-5 years of experience in the pharmaceutical industry.
• Strong verbal and written communication skills.
• Excellent planning, organizational, and time management abilities.
• Ability to adapt to changing priorities, deliverables, and work environments.
• Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
• Strong attention to detail with a commitment to accuracy, quality, and continuous improvement.

Preferred Qualifications:

• Bachelors Degree in scientific or engineering discipline with 1-3 years of relevant experience in a Quality function.
• Quality Assurance experience, including conducting reviews, identifying process gaps, and ensuring compliance with established standards.
• Experience conducting investigations, analyzing information, documenting findings, and making objective, evidence-based recommendations.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

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