Specialist II, QA Complaints

Hikma Pharmaceuticals USA Inc.•Columbus, OH

1d•Onsite

About The Position

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 committed, 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).

Requirements

High school diploma or GED required
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

Nice To Haves

Bachelors Degree in scientific or engineering discipline
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

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.

Benefits

Annual performance bonus
commission
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
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave