GMP Production Documentation Specialist

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 78,000 - 88,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance, Short & Long Term Dis.

Pet Insurance

Generous PTO, Sick & Holiday Time Off

401K

Job summary

Siegfried in Irvine, CA seeks a documentation-focused professional to ensure GMP compliance and accurate batch records for manufacturing and release. You will handle investigations, CAPAs, SOP updates, and coordination with planning and release teams while maintaining ERP records and regulatory alignment.

The role requires strong GMP knowledge, problem-solving, teamwork, and ability to work independently with minimal supervision. Competitive salary and benefits are offered.

Qualifications

• 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

Responsibilities

• Review Batch Records for Commercial Distribution, Media and other relevant documents
• Coordinate collaboration with departments to ensure proper documentation and investigations
• Generate weekly status reports on product manufacturing status
• Assist in writing and amending SOPs to cover significant manufacturing activities
• Review ERP transactions for compliance and timely execution
• Collaborate with management to prioritize work and meet deadlines

Skills

cGMPs

GDPs

Quality Control

Batch Records

Regulatory awareness

Education

Science degree

Job description

Siegfried in Irvine, CA seeks a documentation-focused professional to ensure GMP compliance and accurate batch records for manufacturing and release. You will handle investigations, CAPAs, SOP updates, and coordination with planning and release teams while maintaining ERP records and regulatory alignment.

The role requires strong GMP knowledge, problem-solving, teamwork, and ability to work independently with minimal supervision. Competitive salary and benefits are offered.