Production Documentation Associate

Siegfried • Irvine, CA

4d

About The Position

The Production Documentation Associate ensures manufacturing-area documentation complies with current Good Manufacturing Practices (GMPs) and local procedures. The role reviews production and packaging records and other product documentation, including investigations, deviations, validation reports, and related records. It works with departments across the company to support accurate documentation, timely resolution of issues, appropriate corrective actions, and accurate records of manufacturing studies.

The position provides input on batch releasability and product manufacturing status, maintains status reports and their supporting database, and coordinates production manufacturing and product release with Planning and Product Release. It authors investigation and deviation reports, creates and monitors CAPAs, evaluates deviations for possible escalation to a Process Expert, and makes recommendations for in-process batch dispositions. The role also reviews ERP transactions and commercial-distribution batch records and related documentation, and assists supervisors with writing and updating SOPs.

The associate is expected to prioritize work and meet deadlines, work independently as well as collaboratively, communicate effectively with employees at all levels and external parties, and follow safety policies and procedures. The target salary range is $78,000–$88,000; individual compensation depends on factors including skills, experience, and qualifications.

Requirements

• Degree in a scientific discipline.
• Minimum 8 years of pharmaceutical or related work experience.
• The posting also specifies 3 to 5 years of experience in pharmaceutical manufacturing and/or testing.
• Excellent understanding of cGMPs and GDPs and their importance in quality control and batch-record review.
• Understanding of FDA regulations and guidance and how they apply; fluency in regulatory guidance and its application to regulatory compliance.
• Computer literacy in standard software and database management.
• Problem-solving, analysis, and report-writing skills.
• Good oral communication, teamwork, problem-solving, and basic math skills.
• Excellent written and verbal communication; ability to write and speak clearly and concisely and communicate confidently in a variety of settings.
• Ability to interface with all levels of management, peers, and subordinates.
• Ability to work independently with little or no supervision and collaborate in complex situations.
• Ability to prioritize, meet deadlines, exercise judgment, and request or accept guidance when appropriate.
• Ability to remain calm, self-controlled, and poised under job pressure and responsibility.
• Initiative and manual dexterity.
• Ability to work safely and use material-moving equipment safely.

Nice To Haves

• Aseptic-process experience, including equipment preparation, formulation, sterile filtration, and filling, is strongly preferred.

Responsibilities

• Work with departments across the company, including manufacturing technical representatives, to ensure activities are properly documented, investigations are properly performed, corrective actions are appropriate, issues are resolved promptly, and manufacturing studies are accurately documented.
• Provide accurate input on batch releasability and product manufacturing status, and generate and maintain weekly product-status reports using a database.
• Assist supervisors in writing new SOPs and amending existing SOPs to cover significant manufacturing-area activities and ensure GMP adherence.
• Coordinate production manufacturing and product release with the Planning and Product Release Departments.
• Conduct and write investigations and customer complaints.
• Evaluate deviation incidents and determine whether they should be escalated to a Process Expert.
• Author deviation reports and create, monitor, and track CAPAs through the quality system, including monitoring CAPA completion and effectiveness.
• Make recommendations for in-process batch dispositions.
• Review ERP transactions for compliance and timely execution.
• Review batch records for commercial distribution, media, and other relevant documentation, including batch records, sterilization records, deviations, incident reports, equipment charts, logbooks, validation documentation, and protocols.
• Prioritize work and meet deadlines.
• Communicate and collaborate effectively with coworkers and external parties, work independently with little or no supervision, and support a positive, team-oriented working environment.
• Adhere to safety policies and follow safe work procedures.
• Perform other duties as assigned or as business needs require.

Benefits

• Medical, dental, and vision coverage
• Flexible spending and HSA options
• Life insurance
• Short- and long-term disability
• Pet insurance
• Generous PTO, sick time, and holiday time off
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level