Quality Assurance Associate

RXinsider LTD.; Bedford (OH); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Paid time off (PTO)

Holidays

Health, dental, vision

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio, is seeking a Quality Assurance Associate to perform field QA activities, including in-process checks, AQL inspections, and batch record reviews. You will ensure GMP compliance and support final product release with guidance to manufacturing staff.

The role requires strong QA background, experience with regulatory audits, and ability to write/ revise SOPs and forms. Onsite work and collaboration with cross-functional teams are essential.

Qualifications

• Bachelor’s degree in a relevant science or engineering discipline; associates degree with equivalent experience acceptable.
• 4+ years of relevant cGMP experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred.
• Experience with batch record review, product disposition, and SOPs is a plus.

Responsibilities

• Perform in-process checks, QA approval for area clearance for labeling and packaging.
• Conduct AQL inspections of finished products and QC lab sampling.
• Review batch records and ensure compliance with procedures; resolve discrepancies.
• Lead small projects and train junior staff.
• Interact with FDA and regulatory groups and support GMP events.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Project management

Documentation

Writing skills

Communication skills

FDA interactions

Problem solving

Time management

Education

Bachelor’s degree in science or engineering

Associates degree or equivalent

Tools

Microsoft Office

Job description

Job Title: Quality Assurance Associate

Location: Bedford, Ohio

Job Type: [Full-time]

Req ID: [12375]

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 Quality Assurance Associate to join our team. In this role, you will be responsible for undertaking activities to perform field QA activities: In process checks, QA approval for Area clearance for labelling, packing, AQL inspection for finished products, QC lab sampling for finished products, Retention sampling for finished products, Batch record review, final product release, review and approve various operation documents, forms. Approval or rejection for Raw materials and Final product labels. Ensure compliance of the company’s procedures for In-process activities with the Good Manufacturing Practices (GMPs). Qualified candidate must possess a strong background in Quality Assurance, Quality Compliance and Quality Systems. The qualified candidate must have experience interacting with the FDA and other regulatory/audit groups. This position will be responsible for identifying any deviations or non-conformances, writing/ revising standard operating procedures, forms, protocols, and change controls, and providing guidance to junior staff.

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
• Perform AQL inspection for Finished products
• Create a process flow for QC lab samples to be delivered to the QC lab from production
• Create process flow and perform Raw material and final product inspection and release.
• Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
• Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
• Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
• Review and approval of incoming raw materials, routine preventive, and calibration of equipment.
• Lead small scope projects as assigned.
• Train and mentor junior team members.
• Identify and facilitate continuous improvement project
• Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current on 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.
• Interact with FDA and other regulatory/audit groups. Working knowledge of FDA regulations and application of GMPs

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:

• Education
• Bachelor’s degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.
• Qualifications
• 4+ years of relevant cGMP experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred.
• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
• Preferred: Hands-on experience with batch record review and product disposition is preferred.
• Skills
• Excellent organizational and project management skills and ability to handle multiple projects
• Excellent writing and computer skills and ability to present data in a logical manner
• Excellent interpersonal and communication skills
• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
• Good organization and time management skills.
• Ability to work in a high paced team environment.
• Strong written and verbal skills. Demonstrated effectiveness in task completion, decision making, and problem solving
• Working knowledge of FDA regulations, application of GMPs. Experience interacting with personnel from regulatory agencies.

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.