Specialist I, Quality Assurance
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 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 I, Quality Assurance to join our team. In this role, you will be responsible for supporting Quality Assurance to ensure quality and compliance to regulations with respect to product complaints and product/process deviations. Entry level position to Position will primarily be responsible for supporting QA Complaints (ie. complaint in-box management, complaint intake, complaint follow up, etc.) and QA Investigations (ie. Fact check investigations, investigation triage, etc.) for investigation intake and closure activities.
Requirements
- High school diploma or GED required and 1+ years of industry related experience (pharmaceuticals, food, or bio-science) which provides background for compliance and quality orientation.
- Attention to detail/quality mindset.
- Ability to multi-task to meet deadlines and work quickly under short timelines.
- Demonstrate problem solving skills or troubleshooting skills, ability to identify root cause and assign corrective and preventative actions.
- Demonstrated proficiency in communication skills both verbal and written.
- Demonstrated technical writing skill.
- Flexibility to changing work environment and deliverables.
- Standard business computer skills, MS Word, MS Excel, etc., as required.
- Ability to work within a team setting and provide information and assistance to co-workers and supervisors.
Nice To Haves
- Two (2) years or more of pharmaceutical experience highly desired.
Responsibilities
- Regular and predictable onsite attendance and punctuality.
- Supports Complaint Intake (enter complaints into QMS and support follow ups with Complainant as needed) and QA Investigation triage (complete deviation details, follow up on supporting documents, etc.)
- Conducts simple investigations on Complaints and deviations and documents accordingly.
- Apply investigative techniques to uncover problems, recommend corrective actions, and partner with operations to implement preventative programs for sustained improvement.
- Receive phone calls, voicemails, email, or other inbound communications from product customers and documents product complaints as directed by Standard Operating Procedures.
- Communicates clearly with internal and external customers, peers, and management.
- Actively listens to gain accurate understanding and obtain necessary information to document within investigation records (Complaints and Deviations).
- Support incoming (returned product) and outgoing mail (DEA forms, complainant letters, etc.) requirements through mailroom or warehouse as needed.
- Participates in meetings/discussions with process owners to discuss findings, obtain resolution commitments, and develop recommendations for CAPAs as part of Investigations.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
