In Process QA Specialist

<p><strong><u>About the Company:</u></strong></p>
<p>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.</p>
<p><strong><u>Job Location:</u></strong></p>
<p>Nivagen Pharmaceuticals Inc., Sacramento, CA</p>
<p>3900 Duckhorn Dr, Sacramento, CA 95834</p>
<p><strong><u>About the Job: </u></strong></p>
<p>Title of the Position: In Process QA Specialist (Full Time)</p>
<p>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.</p>
<p><span style="text-decoration: underline;"><strong><span data-contrast="none">Responsibilities:</span></strong><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Perform routine on-the-floor QA oversight within manufacturing areas, providing real-time quality support and ensuring compliance with approved procedures and GMP requirements.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Conduct line clearances, in-process checks, and verification activities during manufacturing and packaging operations.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Review and approve GMP documentation including batch production records, logbooks, sampling records, and associated manufacturing documentation.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">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.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Participate in GMP area walkthroughs and support inspection readiness activities.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Support internal audits, regulatory inspections, and customer audits by preparing documentation and providing operational support.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams to resolve quality issues and drive continuous improvement.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Assist with product disposition activities and quality review processes under supervision.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Promote a culture of quality, compliance, and operational excellence within the organization.</span><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></li>
</ul>
<p><span style="text-decoration: underline;"><strong><span data-contrast="none">Required Skills/Abilities:</span></strong><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">High level of attention to detail, particularly in identifying quality deviations and documenting production processes</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Excellent communication skills, both verbal and written, for effective collaboration and documentation</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Strong organizational skills and attention to detail.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Effective written and verbal communication skills.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Ability to work independently while collaborating within cross-functional teams.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Basic knowledge of deviation management, CAPA, and change control processes preferred.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="none">Familiarity with electronic systems such as Compliance Wire, Track Wise, SAP, LIMS, or similar eQMS platforms preferred.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="none">Proficiency in Microsoft Office applications.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<p><span style="text-decoration: underline;"><strong><span data-contrast="none">Education and Experience:</span></strong><span data-ccp-props="{"201341983":2,"335559740":330}"> </span></span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field OR equivalent combination of education and sterile GMP manufacturing experience.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">0–3 years of experience in sterile pharmaceutical, biotech, or other regulated manufacturing environments.</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Working knowledge of current Good Manufacturing Practices (cGMP) and applicable FDA regulations (21 CFR).</span><span data-ccp-props="{"134233279":true,"134245417":true,"201341983":2,"335559739":150,"335559740":330}"> </span></li>
</ul>
<p><strong><u>Knowledge, Skills, and Abilities:</u></strong></p>
<ul>
<li>Strong analytical and problem-solving skills with experience in root cause analysis and CAPA implementation</li>
<li>High level of attention to detail, particularly in identifying quality deviations and documenting production processes</li>
<li>Proficiency in using quality testing equipment and familiarity with statistical process control (SPC) methods</li>
<li>Strong understanding of GMP, FDA regulations, and other relevant pharmaceutical industry standards</li>
<li>Excellent communication skills, both verbal and written, for effective collaboration and documentation</li>
<li>Ability to work effectively as part of a cross-functional team, including production, quality control, and regulatory affairs</li>
</ul>
<p><strong><u>Job Requirements:</u></strong></p>
<ul>
<li>May require working in shifts, including nights or weekends, depending on production schedules</li>
<li>Adherence to safety protocols, including the use of personal protective equipment (PPE) and compliance with GMP standards, is mandatory</li>
<li>This role requires spending significant time on the production floor, monitoring processes, and conducting tests in a cleanroom or controlled environment</li>
<li>Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)</li>
</ul>
<p><strong><u>Benefits:</u></strong></p>
<ul>
<li>Pay range $80,000-$90,000 per Year</li>
<li>Yearly bonus eligibility</li>
<li>Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being</li>
<li>Medical, dental and vision coverage</li>
<li>Paid time off plan</li>
</ul>
<p><strong><u>Additional Information:</u></strong></p>
<p>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.</p>
<p>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.</p>