Quality Assurance Associate

Hikma•Dayton, OH

17d•$65,000 - $75,000•Onsite

About The Position

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines 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 [Job Title] to join our team. In this role, you will be responsible for [briefly describe key responsibilities and tasks]. You will work closely with [mention teams or departments the role collaborates with] to [describe the role's contribution to the company's success. Job Purpose: Under the supervision of the Quality Assurance Supervisor, this person is responsible for performing field QA activities: in process checks in the aseptic processing area, approval for area clearance, AQL inspection for finished products, retention sampling for finished products, batch record review, final product release, review and approve operation documents and forms, and approval / rejection of in-coming raw materials, components, and final product labels. Ensure compliance of operations personnel with the company’s procedures and Good Manufacturing Practices (GMPs). This position will also be responsible for identifying any deviations or non-conformances, writing deviation reports, performing root cause analysis, writing/revising standard operating procedures and forms, and tracking metrics, when required.

Requirements

Minimum: Associates Degree in Science or equivalent with 2 to 5 years applicable Quality Assurance experience.

Nice To Haves

Preferred: Bachelor’s Degree in Science or equivalent with 1-2 years applicable laboratory, pharmaceutical manufacturing, or related experience (QA preferred)

Responsibilities

Regular and predictable onsite attendance and punctuality.
Perform monitoring of Compounding in the aseptic processing area.
Perform AQL inspection for Finished products
Perform in-coming raw material, component, and labeling inspection and release
Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors.
Provide Quality support to Manufacturing personnel on the floor – providing guidance during GMP events and initiation of deviations and investigations.
Lead small scope projects, as assigned.
Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance.
Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.
Participate in Process Validation activities, including protocol execution and reporting, as necessary.
Working knowledge of FDA regulations and application of GMPs.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% 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.