Production Documentation Associate

Siegfried; Irvine (CA); Presencial; USD 78 000 - 88 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental, Vision

FSA & HSA Options

Life Insurance

Disability (Short & Long Term)

Pet Insurance

Paid Time Off

401K

Resumo da oferta

Siegfried in Irvine, CA seeks a Quality Documentation Specialist to ensure GMP compliance across manufacturing records, investigations and related documents.

You will maintain batch release data, update SOPs, coordinate with Planning/QA, perform investigations, CAPAs, and review ERP transactions while applying FDA guidance.

Strong cGMP knowledge and clear written/verbal communication are essential; target salary range is $78,000 - $88,000.

Qualificações

• Excellent understanding of cGMPs, GDPs and their importance in Quality Control/Batch Record review.
• Computer literacy and database management.
• Exercise judgment in developing practices, techniques and evaluation criteria.
• Good oral, team and problem solving and basic math skills.
• Initiative and manual dexterity.
• Interface with all levels of management, peers and subordinates.
• Remain calm under pressure and communicate clearly with customers and regulators.
• Written and verbal skills; fluent in applying regulatory guidance to compliance.

Responsabilidades

• Document manufacturing activities to ensure GMP compliance and proper investigations.
• Generate weekly status reports for product release and manufacturing status.
• Assist Supervisors to write/update SOPs and ensure GMP adherence.
• Coordinate production release with Planning and Product Release Departments.
• Conduct hands-on investigations and write investigations and customer complaints.
• Evaluate deviations, escalate to a Process Expert, and monitor CAPAs.
• Monitor CAPAs for completion and effectiveness.
• Review ERP transactions for compliance and timely execution.
• Prioritize work and meet deadlines; collaborate with management as needed.
• Understand FDA regulations and apply them to compliance.
• Review Batch Records for Commercial Distribution and related documents.

Conhecimentos

cGMPs & GDPs

Quality Control

Problem solving

Written & verbal communication

Regulatory guidance

Team collaboration

Attention to detail

Data interpretation

Safety awareness

Formação académica

Science degree

Descrição da oferta de emprego

“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.

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_ 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 related work experience. Aseptic process (equipment preparation, formulation, sterile filtration and filling) experience is strongly preferred.

Target salary range is $78,000 - $88,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Your Benefits:

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• Generous PTO, Sick & Holiday Time Off
• 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.