Quality Optimizer II - QA - 2nd Shift (M-F, 3p-1130p)

Job Title:      Quality Optimizer II

Location:      Columbus, OH

Job Type:      Full time

Req ID:          11820

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 continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Quality Optimizer II, QA.

In this role, you will be responsible for ensuring quality and compliance with government regulations and Hikma standards to support the on-going review/audit of batch documentation, release of drug products and supply chain commitments consistent with standard operating procedures and department procedures.

Key Responsibilities:

• Perform detailed production documentation review, shop floor support as needed, identify and communicate quality issues,and drive right-first-time (RFT) in production documentation.


• Specific actions to provide detailed production documentation review:


• Perform detailed review of post execution batch documentation (master formula cards, master packaging specifications, electronic batch records)


• Support production shop floor with documentation/quality issues as escalated by Production Optimizers


• Verify compliance with applicable SOP's, WI's and cGMP practices, providing interpretation and application as needed


• Collect quality metric data; Support and drive site/department goals and expectations.


• Supports implementation of EBR process implementation by executing EBR Process Qualification evaluations and reviews. Ensure EBR documentation system accurately reflects manufacturing process utilizing side-by-side review with current paperlot documentation. Continue developing EBR skill set to become SME. Support continuous improvement of the EBR system through feedback and partnering with the MES team.


• Develop and deliver training to operations to support RFT and cGMP compliance.


• Apply knowledge of cGMPs, other regulatory requirements, and internal processes.


• Represent QA Disposition at Job Board, Performance to Plan, Sequencing and New Product Launch meeting.


• Drive area procedural robustness and cGMP compliance through document authoring and review (SOPs, WIs, Re-inspection Instructions).


• Frequently have to help document a non-standard event during production, maintaining accuracy while effectively communicating critical details so that it can be easily understood by an external auditor. Decision making can significantly impact customer service level. Incorrect judgment concerning corrective action can delay release of product, require re-inspection activities or potentially lead to a market action.


• A QA Disposition Quality Optimizer II has the authority to perform a detailed review of executed lot documents but does not have the authority to perform final disposition (release or reject) decisions. A QA Disposition Quality Optimizer II has full authority to develop path forward when addressing non-standard events and documentation errors although additional support from the Quality unit or other QA Disposition Quality Optimizers may be needed. Any decision that can be supported by Procedures and cGMPs is within the QA Disposition Quality Optimizer II authority. A QA Disposition Quality Optimizer II is expected to investigate and pursue innovative solutions and techniques to optimize QA Disposition.


• Peer and supervisor consultation is expected if there is a significant question pertaining to correct path forward. Decisions to refer to a supervisor include instances where there is critical impact and a lack of data, or conflicting data upon which to make the decision.

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:

• B.S. in Biology, Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 2 years pharmaceutical operations experience.


• In lieu of BS in scientific discipline, High School Diploma or GED plus a minimum of 6 years of pharmaceutical experience, in an area that provides a knowledgeable background for compliance and quality orientation.


• Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel), SAP and EBR is a plus.


• Proven ability to establish and maintain effective working relationships with managers and employees.


• Possess excellent communication skills with the ability to influence/ persuade individuals of various levels within the organization to gain understanding and/or acceptance of an idea, policy, procedure or plan. Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust and build strategic relationships.


• Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment.


• Proven ability to shift thought processes quickly and accurately from one project to another.


• Ability to lift 20 pounds.

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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