Title:  Specialist, Document Control (Quality)

Job Title:          Specialist, Document Control

Location:         Columbus, OH

Job Type:          Full time

Req ID:              11148

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 Specialist, Document Control to join our team.  

In this role, you will be responsible for writing and/or reviewing various document classes to support the release and on-going regulatory and supply chain commitments consistent with standard operating procedures and department procedures:

Document Control Generation

• Annual Stability Reports (ASR)
• CofAs (Certificate of Analysis)
• Stability Commitment and Protocols (SC/P)
• Annual Product Review (APR)
• ASTRs (statistical annual product review)
• Statements (e.g. BSE/TSE, Melamine, etc.)
• Testing Specifications/Analytical Procedures

Document Control Review

• Operations (MFC, MPS, Master Design Specifications (MDS), EBR)
• Labeling (MLS)
• Back up for Issuance of Master Documentation

Records Retention

Audit Support.

Key Responsibilities:

Document Generation:

• Responsible for writing/revising and or reviewing ASRs, SC/P, APRs and SAPRs in accordance with standard operating procedures (SOP’s) and departmental procedures (work instructions). 
• Author and/or approve (CofAs) for finished products or raw materials as requested.
• Support updates of specifications/analytical procedures as per internal and external timelines.  Duty is required as part of change control for either continuous improvements to documentation or updates to current compendia (USP, EP, etc.).
• Research, author and/or approve requests for regulatory statements for products or raw materials as requested.
• Drive adherence to process with regards to creation of analytical procedures, specifications, stability protocols/reports, statements and annual product reviews for alignment to standard conventions.

Document

• Support the change control review and approval process for operations documentation (MFC, MPS) and the ancillary Master Data requirements.
• Support the change control process for labeling via the GLAMS system and the necessary MLS and guardian systems.
• Ensure the paper change control process for Master Manufacturing Formula Cards, Master Packaging Specifications and applicable technical reports.
• Review, support the change control process which supports the development, implementation and maturation of the Electronic Batch Record Change Control process. Interface with MES team to support quality mindset and input on quality related concerns. 
• Support timely retrieval of records for inspections.
• Other duties as assigned

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:

• Bachelor’s degree (Chemistry and/or Engineering and/or Biology) or a minimum of 3 years combination of quality, production, engineering and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP requirements. 
• Proficient computer skills in Microsoft (MS) Word, Excel, PowerPoint and Access required. 
• Demonstrated ability to organize and analyze statistical and technical data and prepare comprehensive written reports as required.
• Change Management experience to ensure proper guidance and leading of changes across multiple disciplines.
• Knowledge of stability requirements to ensure proper on-going evaluation are occurring to meet regulatory commitments.
• Proven ability to establish and maintain effective working relationships with managers and peers.
• Demonstrated ability to motivate others to create an environment open to change and learning.
• 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.
• Demonstrated ability to comprehend, analyze and interpret process and systems information, technical procedures and governmental regulations.
• Proven ability to shift thought processes quickly and accurately from one project to another.

Preferred Qualifications:

• Experience with SAP, Trackwise and PMX.
• Laboratory experience.

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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