Position Summary:

The Quality Assurance Document Control Specialist is a quality focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements, approved procedures, and ensures completed records are accurate and compliant. Assist in the day-to-day record management activities within Bell International Laboratories complying with company and regulatory requirements.

Responsibilities

• Perform QA document control functions, including document logging, tracking, processing, review, distribution, release and archiving of documents.
• Review, approve and formally release batch records that comply with requirements.
• Coordinate the revision, review, and approval and obsoleting of SOPs and other GMP documents. Responsible for ensuring compliance with document control requirements, such as periodic review of documents.
• Facilitate improvements to procedures by working with document owners to resolve conflicts and improve compliance, effectiveness and efficiency.
• Organize and ensure accurate and reliable filing systems for GMP documents, including electronic systems.
• Assure easy retrieval of documents for customers, including Certificates of Analysis.
• Maintain in house training programs including training matrix, training files and annual audit of training files.
• Maintain and execute (as assigned) key aspects of the quality system such as: IQOQ, document control, CAPA, Change Control, Deviations, OOS’s, Annual Product Review, Supplier Qualifications and Controls.
• Actively participate in internal audits, customer audits, supplier audits, and other activities as assigned by manager.
• Create Annual Product Reviews for all OTC products.

Requirements

Required Skills/Abilities

• Proficient at reviewing and editing documentation.
• Familiar with cGMP’s and the ability to follow standard operation procedures.
• Excellent written, verbal and interpersonal communication skills.
• Strong critical thinking and problem-solving skills.
• Ability to prioritize multiple responsibilities and manage deadlines accordingly.
• Communicate effectively with all members of organization and all levels of management.
• Exceptional attention to detail and high level of accuracy & organization.
• Ability to work independently with minimal supervision in a fast-paced environment.
• Ability to adapt quickly to changing policies and procedures.
• Exhibit a quality mindset and a willingness to develop yourself and others.
• Proficient with Microsoft Office and Adobe Acrobat.

Required Education and Experience

• Associate’s degree in scientific discipline.
• 2-5 years of hands on experience with document management in a regulated industry (pharmaceutical or medical device industries).

Preferred Education and Experience

• Bachelor’s degree in scientific discipline.
• Demonstrated knowledge of cGMP’s, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.
• Experience with audits in regulated environment.
• Knowledge of laboratory equipment set-up and operation, common laboratory techniques and safe chemical handling.

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.