Production Documentation Associate

Siegfried • Irvine, CA

6d • $78,000 - $88,000

About The Position

The Production Documentation Associate ensures manufacturing-area documentation complies with 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 across departments to support accurate documentation, timely resolution of issues, batch release decisions, and coordination of manufacturing and product release. The position also reviews ERP transactions, supports SOP development, and authors and monitors investigations and CAPAs. It requires effective collaboration and communication, independent work with little supervision, adherence to safety policies, and the ability to prioritize work and meet deadlines.

Requirements

• Degree in a scientific discipline.
• Minimum 8 years of pharmaceutical or related work experience.
• 3 to 5 years of experience in pharmaceutical manufacturing and/or testing is also stated in the posting.
• Excellent understanding of cGMPs and GDPs and their importance in quality control and batch record review.
• Computer literacy, including standard software and database management.
• Ability to exercise judgment in developing practices, techniques, and evaluation criteria to obtain results.
• Good oral communication, teamwork, problem-solving, and basic math skills.
• Initiative and manual dexterity.
• Ability to interface with all levels of management, peers, and subordinates.
• Ability to remain calm, self-controlled, and poised under job pressure and responsibility.
• Ability to work safely and use material-moving equipment safely.
• Excellent written and verbal communication skills, including clear and concise writing and speaking.
• Confidence and effectiveness communicating in varied settings with internal and external audiences, including customers, vendors, and regulatory authorities.
• Fluency in regulatory guidance and understanding of its application to regulatory compliance.
• Ability to prioritize work, meet deadlines, and recognize non-compliant issues while seeking or accepting guidance as appropriate.

Nice To Haves

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

Responsibilities

• Work with departments and manufacturing technical representatives to ensure activities are properly documented, investigations are properly performed, corrective actions are appropriate, issues are resolved promptly, and manufacturing special studies are accurately documented.
• Provide input on batch releaseability and product manufacturing status, generating weekly product status reports and maintaining them in a database.
• Assist supervisors with writing new SOPs and amending existing SOPs for manufacturing activities and 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, determine whether escalation to a Process Expert is appropriate, author deviation reports, and create and monitor CAPAs through the quality system.
• Make recommendations for batch dispositions in process and monitor CAPAs for completion and effectiveness.
• Review ERP transactions for compliance and timely execution.
• Review batch records for commercial distribution, media, and other relevant documentation, including sterilization records, deviations, incident reports, equipment charts, logbooks, validation documentation, and protocols.
• Communicate and collaborate effectively with coworkers and employees at all levels, and work independently with little or no supervision.
• Adhere to safety policies and safe work procedures, including safe use of material-moving equipment.
• Maintain a positive working environment that encourages teamwork and mutual support.
• 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, and holiday time off
• 401(k)

What This Job Offers

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