Document Control Specialist

West Pharmaceutical Services, Inc; Williamsport (Lycoming County); On-site; USD 60,000 - 80,000; Full time

Job summary

Une entreprise pharmaceutique en pleine croissance recherche un Document Control Specialist pour s'assurer que les processus de documentation respectent les exigences réglementaires. Ce rôle clé inclut la gestion de la documentation et le soutien lors des audits internes/externes. Le candidat idéal a une attention aiguë aux détails, des compétences exceptionnelles en communication, et une capacité à travailler de manière autonome dans un environnement dynamique.

Qualifications

• 3 ans d'expérience en assurance qualité/contrôle qualité dans un environnement réglementé.
• Expérience avec les systèmes de gestion de documents dans l'industrie réglementée nécessaire.
• Connaissance des normes ISO 9001, ISO 13485, 21 CFR 820 préférée.

Responsibilities

• Gérer le système de documentation pour assurer la conformité réglementaire.
• Effectuer des fonctions de contrôle documentaire, y compris la révision et le suivi.
• Assurer la documentation dans le respect des exigences internes et externes.

Skills

Problem Solving

Interpersonal Skills

Communication

Attention to Detail

Education

Associate's Degree

Bachelor's Degree

Tools

MasterControl

SAP

Share Point

Microsoft Office Suite

Job description

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Title: Document Control Specialist

Requisition ID: 70365

Location:

Williamsport, Pennsylvania, US

Department: Quality

Description:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this role, you will support the document system to ensure documentation and record keeping processes conform to regulatory requirements as well as internally approved procedures. Distribute documentation necessary to perform cGMP activities and maintain customer documentation. This role will also be responsible for executing transactions in relevant GMP systems (MasterControl, SAP, Share Point) and other quality functions as applicable including site audit support.

Essential Duties and Responsibilities

• • Manage and maintain traceable, accountable, password protected, documentation system in compliance with site and corporate guidelines to handle the needs of the facility for WKIs, SOPs, ESOPs, validations, training, and other various documentation.
  • Provide instruction on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
  • Performs document control functions, including document review, editing, tracking, processing, approval, distributing, issuance and archiving in compliance to internal and external requirements.
  • Interface with department(s) SMEs with the development and documentation of problem statements, containment, implementation, correction, root cause, action plan, risk management and effective monitoring with NCRs, Issue Reviews, Complaints, and CAPAs.
  • Provide support with the customer change notification and calibration process, internal/external audits, document and record control, batch review, issue reviews, complaints, CAPAs, and shipment requirements.
  • Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  • Maintain documentation to ensure compliance with internal procedures and regulatory requirements.
  • Maintain electronic document control system to ensure prompt retrieval of documents.
  • Review documentation for accuracy and conformance to established guidelines, policies, and practices.
  • Conducts periodic reviews of all documents to maintain consistency alignment to customer, corporate, regulatory, or standard requirements.
  • Write or assist with the development of procedures and work instructions.
  • Prepares and generates reports related to document control by collecting, analyzing and summarizing data.
  • Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems.
  • Serve as System Sub-administrator of the document management system.
  • Develop training material and perform training for document and record control.
  • Provide support with the internal/external audits to include monitoring audit findings.
  • Audit facilities/departments for compliance to the documented QMS and cGMP requirements.
  • Contributes to continuous process improvement efforts.
  • Other duties as assigned.

Education

• Associate's Degree in technical or business-related field required and
• Bachelor's Degree preferred

Work Experience

• Minimum 3 years of experience in regulated Quality Assurance / Quality Control required and
• Relevant work history and/or experience may be considered in lieu of degree required and
• Experience with managing Document Control activities within a regulated industry required and
• Experience with quality systems such as ISO 9001, ISO 13485, 21 CFR 820 preferred and
• Experience with MasterControl (preferred) or electronic document management systems

Preferred Knowledge, Skills and Abilities

• A thorough working knowledge of quality systems and Good Manufacturing Practices including Good Documentation Practices.
• Experience in Quality Systems Auditing against recognized Medical Device/Pharmaceutical Manufacturing Standards.
• Experience in supporting regulatory audits from US Regulatory Authorities.
• Experience with MasterControl, SAP, Share Point, Teamcenter, eCTR.
• Must have effective problem solving and interpersonal skills.
• Ability to read, write and follow verbal and written instructions.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Excellent written and verbal communication skills.
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point.
• Ability to make and implement decisions based on experience and facts as well as provide direction to peers or less experienced team members.
• Must have excellent communication and written skills.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.

Travel Requirements

5%: Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in orderto apply to West, please send an email to [e-mail] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.