In Process QA Associate

In Process QA Specialist

Nivagen Pharmaceuticals, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

Title of the Position: In Process QA Specialist (Full Time)

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.

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.

Qualifications:

Education/Experience:

Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience.

03 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.

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.

Knowledge, Skills, and Abilities:

• 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

Job Requirements:

Physical / Mental Requirements

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.

Work Environment / Schedule

Primarily day shift, MondayFriday.

May require flexibility to support manufacturing operations, including occasional off-shift or weekend coverage.

Work Location Assignment: On-site / Manufacturing Facility

This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles' radius)

Benefits:

• Pay range $70,000 - $80,000 per Year
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.