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Document Control Specialist - Menlo Park, United States - Actalent
Description
Job Description:
Review and approve master batch records, labels, specifications and other
pre-production documents for Clinical/Commercial Drug Product in compliance
with FDA and international health agency requirements.
• Review executed production batch records, environmental monitoring data (as
required), and associated documentation, including any deviation and
investigation reports related to lot release of Clinical/Commercial Drug
Product in support of product disposition.
• Lead or coordinate investigations and corrective and preventive action (CAPA)
recommendations
• Interface directly with contract manufacturers and alliance partners to
manage quality related issues with minimal supervision.
• Interact with key stakeholders such as Formulation and Process Development,
Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that
Clinical/Commercial Drug Products are manufactured in accordance with
established procedures, cGMPs, and appropriate regulations.
• Reviews manufacturing, environmental monitoring and quality control data for
in process and finished products with guidance from senior colleagues.
• Works with operating entities with guidance from senior colleagues to ensure
that inspections, statistical process control analyses and audits are conducted
on a continuing basis as specified to enforce requirements and meet
specifications.
• Write, revise, and review standard operating procedures.
• Participates in developing Standard Operating Procedures (SOPs) to ensure
quality objectives are met.
• Maintains routine programs and processes to ensure high quality products and
compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory
Practices GLPs).
• Works with Research and Development during new product start-ups and
identifies checkpoints for new products and processes.
• Normally receives very little instruction on routine work, general
instructions on new assignments.
• Assist in departmental planning activities to ensure that deliverables are
provided according to project timelines
Essential Duties and Job Functions:
• Performs a wide variety of activities to ensure compliance with applicable
regulatory requirements.
• Participates in developing Standard Operating Procedures (SOPs) to ensure
quality objectives are met.
• Maintains routine programs and processes to ensure high quality products and
compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory
Practices GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for
in-process and finished products.
• Works directly with operating entities to ensure that inspections,
statistical process control analyses and audits are conducted on a continuing
basis as specified to enforce requirements and meet specifications.
• May participate in the writing of annual product reviews and the development
of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator of investigations and corrective
and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start-ups and
identifies checkpoints for new products and processes.
• Normally receives very little instruction on routine work, general
instructions on new assignments
Additional Skills & Qualifications:
• Good working knowledge of Quality Systems, FDA/EMEA Standards, current Good
Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• Excellent knowledge of six sigma, LEAN and root cause analysis tools for
identifying and correcting deviations
• Ability to work on complex, non-routine assignments where analysis of the
situation or data requires a review of identifiable factors
• Ability to effectively participate in cross-functional teams
• Ability to coordinate the planning, organization, and implementation of
project deliverables within specified objectives
• An accountable team player who is detail and quality oriented with solid
understanding of quality assurance principles, systems, and procedures
• Excellent attitude with strong verbal, technical writing, and interpersonal
communication skills
• Self-starter, able to work independently
• Experienced business traveler a plus (approximately 10%)
Basic Qualifications:
• 4+ years of relevant experience in a GMP environment related field and a BS
OR 2+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry is beneficial.
• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs)
and/or Good Laboratory Practices (GLPs).
• Demonstrates working knowledge of quality assurance systems, methods and
procedures.
• Demonstrates knowledge of FDA / EMEA standards and quality systems.
• Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis
tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates proficiency in Microsoft Office applications.
Experience Level:
Mid Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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