In Process QA Specialist

Nivagen Pharmaceuticals; Sacramento (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Yearly bonus eligibility

Job summary

Nivagen Pharmaceuticals is seeking an In Process QA Specialist in Sacramento to ensure pharmaceutical products meet quality standards during manufacturing. You will monitor, sample, test, and document processes to maintain GMP and regulatory compliance.

Responsibilities include line clearances, in-process checks, document review, and supporting deviation investigations with CAPA development. Collaboration with Manufacturing and QA teams is essential to drive continuous improvement.

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field or equivalent GMP experience.
• 0–3 years in sterile GMP environments with knowledge of cGMP and FDA regulations.
• Strong data handling, documentation, and CAPA/root cause analysis experience.

Responsibilities

• Perform on-the-floor QA oversight in manufacturing areas with real-time quality support.
• Conduct line clearances, in-process checks, and verification during operations.
• Review GMP documentation: batch records, logbooks, and sampling records.
• Support deviation investigations and CAPA development and follow-up.

Skills

Root cause analysis

CAPA implementation

GMP knowledge

FDA regulations understanding

SPC familiarity

Documentation precision

Cross-functional collaboration

On-the-floor QA oversight

Education

Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field

Tools

Compliance Wire

TrackWise

SAP

LIMS

Job description

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Job Location:

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

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.

Required Skills/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.
• 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 Compliance Wire, Track Wise, SAP, LIMS, or similar eQMS platforms preferred.
• Proficiency in Microsoft Office applications.

Education and Experience:

• 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).

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:

• Adherence to safety protocols, including the use of personal protective equipment (PPE) and compliance with GMP standards, is mandatory
• This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius)
• 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

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.