Production Documentation Associate

Siegfried AG; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

Siegfried AG in Irvine, CA seeks a documentation and quality/compliance professional to ensure GMP documentation and batch records are complete and accurate.

You will collaborate across manufacturing and QA, review investigations and deviations, write CAPA actions, and help ensure on-time product release and regulatory compliance.

Strong attention to detail, knowledge of cGMPs, and ability to work with multiple departments are essential in this role.

Qualifications

• Excellent understanding of cGMPs, GDPs and their importance in Quality Control/Batch Record review.
• Proficient computer skills and database familiarity to manage records and reports.
• Ability to interface with all levels of management and stakeholders.

Responsibilities

• Review batch records and related documents for compliance and accuracy.
• Investigate deviations and prepare CAPA-related documentation and reports.
• Coordinate with manufacturing, planning and QA for product release and documentation.
• Assist in writing and updating SOPs to reflect current practices.
• Monitor regulatory guidance and ensure adherence across processes.

Skills

cGMPs GDPs

Regulatory knowledge

Documentation

Problem solving

Team collaboration

Education

Science degree

Tools

ERP systems

Job description

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact.

Your Role:

Scope and Purpose of Position

This position will be responsible to ensure all the documentation from the manufacturing area is in compliance with the GMPs and with the local procedures. It also ensures the production and packaging records are properly completed and reviewed, as well as other relevant product information such as investigation, deviation, validations reports and related documents.

Your Profile:

Responsibilities

• Works with all departments of the company including technical representatives from manufacturing to assure that the activities are properly documented, investigations are properly performed, and the corrective actions are adequate and appropriate; all issues are resolved in a timely manner and that any special studies performed in manufacturing are accurately documented.
• Provides accurate input into the release ability of batches and the manufacturing status of all products be generating on a weekly basis a status report for products. Updates and maintains these reports via a database.
• Assist Supervisors to write new SOPs and amend current SOPs to accurately cover all significant activities within the manufacturing area and ensure adherence to the GMPs.
• Coordinates production manufacturing and product release with the Planning and Product Release Departments.
• Personnel in this position will be hands-on investigations and writing of investigations and customer complaints.
• This position is responsible for evaluating deviations incidences and determining if each should be escalated to a Process Expert. Authoring the deviation report and creating and monitoring the execution of CAPAs through the quality system, as well as making recommendations for batch dispositions in process.
• Monitor CAPAs for completion and effectiveness.
• Responsible for reviewing ERP transactions for compliance and timely execution.
• Must be able to prioritize work and meet deadlines. Must have strong understanding of what constitutes non-compliant issues but is equally ready to request and accept guidance from department management or question matters.
• Understanding of FDA regulations and guidance information as well as thorough understanding of how they are applied is essential to this position.
• Responsible for the review of all Batch Records for Commercial Distribution, Media and all other relevant documents. This documentation includes but is not limited to Batch Records, Sterilization Records, Deviations, Incident Reports, Equipment Charts, Logbooks, supporting validation documentation, and protocols.
• Other duties as assigned or as business needs require.
• Able to communicate effectively and work well in a team group setting.
• Able to collaborate with fellow employees in a variety of complex situations.
• Requires synergy with department members as well as company co-workers. Able to work independently with little or no supervision.
• Responsible for adhering to safety policies and following safe work procedures.
• Maintain a positive working environment that encourages teamwork and mutual support.

Required Knowledge, Skills and Abilities

Excellent understanding of cGMPs, GDPs and their importance in Quality Control/ Batch Record review. Computer Literacy in standard software as well as database management. Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results. Good oral, team and problem solving and basic math skills Initiative and manual dexterity Must be able to interface with all levels of management, peers and subordinates. Remains calm, self-controlled, and poised under all types of job pressure and responsibility. Ability to work safely and use all material moving equipment in a safe manner Excellent written and verbal skills. Writes and speaks clearly and concisely. Is effective and confident when communicating in a variety of settings both internally and externally, with customers, vendors and with regulatory authorities. Fluent in regulatory guidance's and understanding of how they are applied to regulatory compliance.

Required Education and Experience

Degree in a scientific discipline with 3 to 5 years' experience in pharmaceutical manufacturing and/ or testing. Good computer skills and ability to work with all levels. Must be skilled at problem solving analysis and Reporting writing. Minimum 8 years of Pharmaceutical or relate