In Process QA Associate

Nivagen Pharmaceuticals•Sacramento, CA

57d•$70,000 - $80,000•Onsite

About The Position

At Nivagen as an In Process QA Specialist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements.

Requirements

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience.
0–3 years of experience in sterile pharmaceutical, biotech, or other regulated manufacturing environments.
Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations (21 CFR).
Strong organizational skills and attention to detail.
Effective written and verbal communication skills.
Ability to work independently while collaborating within cross-functional teams.
Ability to apply sound judgment and make decisions aligned with company procedures and regulatory standards.
Strong analytical and problem-solving skills.
Ability to gown and work within controlled cleanroom environments.
Must be able to wear appropriate PPE (safety shoes, glasses, gloves, etc.).
Ability to stand for extended periods during manufacturing oversight activities.
Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Nice To Haves

Basic knowledge of deviation management, CAPA, and change control processes preferred.
Familiarity with electronic systems such as ComplianceWire, TrackWise, SAP, LIMS, or similar eQMS platforms preferred.
Proficiency in Microsoft Office applications.
Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation
High level of attention to detail, particularly in identifying quality deviations and documenting production processes
Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods
Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards
Excellent communication skills, both verbal and written, for effective collaboration and documentation
Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs

Responsibilities

Perform routine on-the-floor QA oversight within manufacturing areas, providing real-time quality support and ensuring compliance with approved procedures and GMP requirements.
Conduct line clearances, in-process checks, and verification activities during manufacturing and packaging operations.
Review and approve GMP documentation including batch production records, logbooks, sampling records, and associated manufacturing documentation.
Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks.
Support the authoring, review, and approval of QA Manufacturing procedures, controlled documents, and Master Batch Records to ensure compliance with cGMP, regulatory requirements, and internal quality standards.
Participate in GMP area walkthroughs and support inspection readiness activities.
Support internal audits, regulatory inspections, and customer audits by preparing documentation and providing operational support.
Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams to resolve quality issues and drive continuous improvement.
Assist with product disposition activities and quality review processes under supervision.
Promote a culture of quality, compliance, and operational excellence within the organization.