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QA Document Control Specialist

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Job Type

Full Time

Benefits

Health

Dental

Vision

Short Term Disability

Long Term Disability

Life Insurance

PTO

401(k)

The Quality Assurance Document Control Specialist is a quality focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements as well as Bell Int. Labs approved procedures and output documents are accurate. The individual will assist in the day to day record management activities within Bell Labs complying with company and regulatory requirements.

Responsibilities

  • Performs QA document control functions, including document login, tracking, processing, review, distribution, release and archiving of documents.
  • Coordinates the revision, review, and approval and obsoleting of SOPs and other GMP documents. Responsible for ensuring area managers perform annual review of all cGMP documents and SOPs.
  • Organizes and ensures accurate and reliable filing systems for all paper-based GMP documents.
  • Maintains in house training programs including training matrix, training files and annual audit of training files.
  • Maintain SOP binders.
  • Maintains change control and deviation processes for SOPs, master batch records, specifications, test methods, validation protocols/reports, technical protocols, reports, and other GMP documents.
  • Actively participates in internal audits, customer audits and other activities as assigned by manager

Requirements

Required Skills/Abilities
  • Ability to work independently with minimal supervision in a fast-paced environment
  • Prioritize multiple responsibilities and manage deadlines accordingly
  • Ability to establish personal and professional credibility in the organization
  • Acute attention to detail and high level of organization and accuracy
  • Proactive nature – must want to learn and develop in the role
  • Ability to adapt quickly to changing policies and procedures
  • Ability to analyze and solve problems
  • Proficient with Microsoft Office
Required Education and Experience
  • Bachelor’s degree in scientific discipline preferred
  • Quality professional with 2-5 years of hands on experience with document management in a regulated industry–pharmaceutical or medical device industry–with direct document control experience.
  • Must be well-organized and proficient at reviewing and editing documentation.
  • Can maintain attention to detail while executing multiple tasks.
  • Must be skilled in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat.
  • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
  • Ability to effectively build and maintain relationships, communicating and interacting in a matrix environment
Preferred Education and Experience
  • Exhibit a quality mindset and a willingness to develop yourself and others.
  • Demonstrated knowledge of GMPs, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.
  • Audit or inspection experience preferred.

Additional Information

EEO Statement

Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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