PCI Pharma Services is hiring: Manufacturing Investigator I (Batch Record Author
PCI Pharma Services, San Diego, CA, United States
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary
Under direct supervision, this position may investigate, author, coordinate, and revise deviations, corrective and preventative actions, complaints, and other cGMP documents such as Master Production Batch Records. The Manufacturing Investigator I supports simple write‑ups and the resolution of issues or risks related to Manufacturing. This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation.
Essential Job Functions – Other Duties May Be Assigned
Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations. May support cross‑functional teams.
Authors and revises batch records, deviations, complaints, and other technical documentation.
Manages specific components of large‑scale deviations.
Tracks and trends relevant documentation and data as specified.
Maintains a GLP/cGMP environment and follows SOPs.
Adjusts responsibilities and activities to meet client and internal expectations.
Follows up on open documents to ensure timely close‑out of batch record revisions and investigations.
Provides support for internal and client audits as needed.
Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
Regular and reliable attendance on a full‑time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Education and Experience
Associate’s or bachelor’s degree preferred. High School diploma or equivalent required.
0–2 years of relevant experience in manufacturing.
Minimum of 1 year of relevant experience in a cGMP environment preferred.
Previous investigations experience preferred.
Familiarity with relevant technical documentation (SOPs, preventative actions, deviations, etc.) preferred.
Detail oriented with strong English writing skills.
Strong verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Highly proficient with Microsoft Office applications.
Physical Demands
Constantly required to sit, and to reach to use computers and other office equipment.
Occasionally stand for extended periods of time, up to four (4) hours/time.
Occasionally required to lift up to 10 pounds.
Frequently required to view objects at close and distant ranges with hand and eye coordination.
Constantly required to communicate with others.
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Work Environment
Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio‑hazardous materials. The work environment is fast‑paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off‑shift, weekend and overtime duties may be required.
The hiring rate for this position is $19.54–$21.98 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full‑time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
Join us and be part of building the bridge between life‑changing therapies and patients. Let’s talk future.
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ: For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair‑chance
#J-18808-Ljbffr
In Summary: The Manufacturing Investigator I supports simple write‑ups and the resolution of issues or risks related to Manufacturing . This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation . The position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment .
En Español: Tratamientos que cambian la vida. Impacto global. Puente a miles de compañías biofarmacéuticas y sus pacientes. Somos PCI Nuestra inversión es en personas que producen impacto, impulsan el progreso y crean un mañana mejor. Nuestra estrategia incluye construir equipos en toda nuestra red mundial para ser pioneros y dar forma al futuro del PCI. Resumen Bajo supervisión directa, esta posición puede investigar, escribir, coordinar y revisar desviaciones, acciones correctivas y preventivas, reclamaciones y otros documentos cGMP como Master Production Batch Records. Puede apoyar equipos interfuncionales. Autores y revisar registros de lotes, desviaciones, quejas y otra documentación técnica. Gestiona componentes específicos de desvios a gran escala. Realiza seguimiento y tendencias de la documentación y datos relevantes según lo especificado. Mantiene un entorno GLP/cGMP y sigue SOPs. Ajusta responsabilidades y actividades para satisfacer las expectativas del cliente y internas. Seguir documentos abiertos para garantizar el cierre oportuno de revisiones e investigaciones de los registros por lotes. Proporciona apoyo para auditorías internas y de clientes cuando sea necesario. Familiariza con nuevos equipos, sistemas y tecnologías para crear y mantener una documentación precisa. Asistencia regular y fiable en tiempo completo [o de acuerdo con el horario publicado]. Responsable de mostrar comportamiento profesional tanto interno como externo que refleje positivamente las políticas y prácticas culturales de la compañía y las acciones asociadas. Se requiere un diploma de escuela secundaria o equivalente. 02 años de experiencia relevante en la fabricación. Se prefieren al menos 1 año de experiencia pertinente en un entorno cGMP. Se precisan experiencias previas con investigaciones. Se preferen conocimientos técnicos pertinentes (SOPs, acciones preventivas, desviaciones, etc.). Este puesto tiene la máxima responsabilidad de cumplir con las reglas y regulaciones relativas a un entorno laboral seguro y saludable en relación con sus acciones y conducta. Puede requerirse tareas fuera del turno, durante el fin de semana o horas extras. La tasa de contratación para este puesto es de $19.54$21.98 más la elegibilidad para una bonificación anual de rendimiento. Las cantidades de ofertas finales se determinan por múltiples factores, incluidos pero no limitados a experiencia específica y relevante, educación, credenciales, geografía y conocimientos sobre temas relacionados. PCI ofrece a los empleados de tiempo completo un paquete de beneficios competitivos que incluye vacaciones pagadas, cobertura de seguros médicos (incluyendo salud dental y visión), estatus de gasto flexible y un plan 401k. Únete a nosotros y sea parte de construir el puente entre Equapies e pacientes que cambian su vida. Estamos comprometidos a cultivar un lugar de trabajo inclusivo manteniéndonos responsables de los más altos estándares de comprensión, equidad, respeto y igualdad de oportunidades en todos los niveles. Imaginamos una comunidad PCI donde todo el mundo pueda pertenecer y crecer, y nos esforzamos por hacer realidad esta visión evaluando continuamente e intencionadamente nuestras prácticas personales, políticas y programas, enfoque de marketing y cultura laboral.
We are PCI
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary
Under direct supervision, this position may investigate, author, coordinate, and revise deviations, corrective and preventative actions, complaints, and other cGMP documents such as Master Production Batch Records. The Manufacturing Investigator I supports simple write‑ups and the resolution of issues or risks related to Manufacturing. This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation.
Essential Job Functions – Other Duties May Be Assigned
Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations. May support cross‑functional teams.
Authors and revises batch records, deviations, complaints, and other technical documentation.
Manages specific components of large‑scale deviations.
Tracks and trends relevant documentation and data as specified.
Maintains a GLP/cGMP environment and follows SOPs.
Adjusts responsibilities and activities to meet client and internal expectations.
Follows up on open documents to ensure timely close‑out of batch record revisions and investigations.
Provides support for internal and client audits as needed.
Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
Regular and reliable attendance on a full‑time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Education and Experience
Associate’s or bachelor’s degree preferred. High School diploma or equivalent required.
0–2 years of relevant experience in manufacturing.
Minimum of 1 year of relevant experience in a cGMP environment preferred.
Previous investigations experience preferred.
Familiarity with relevant technical documentation (SOPs, preventative actions, deviations, etc.) preferred.
Detail oriented with strong English writing skills.
Strong verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Highly proficient with Microsoft Office applications.
Physical Demands
Constantly required to sit, and to reach to use computers and other office equipment.
Occasionally stand for extended periods of time, up to four (4) hours/time.
Occasionally required to lift up to 10 pounds.
Frequently required to view objects at close and distant ranges with hand and eye coordination.
Constantly required to communicate with others.
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Work Environment
Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio‑hazardous materials. The work environment is fast‑paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off‑shift, weekend and overtime duties may be required.
The hiring rate for this position is $19.54–$21.98 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full‑time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
Join us and be part of building the bridge between life‑changing therapies and patients. Let’s talk future.
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ: For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair‑chance
#J-18808-Ljbffr
In Summary: The Manufacturing Investigator I supports simple write‑ups and the resolution of issues or risks related to Manufacturing . This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation . The position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment .
En Español: Tratamientos que cambian la vida. Impacto global. Puente a miles de compañías biofarmacéuticas y sus pacientes. Somos PCI Nuestra inversión es en personas que producen impacto, impulsan el progreso y crean un mañana mejor. Nuestra estrategia incluye construir equipos en toda nuestra red mundial para ser pioneros y dar forma al futuro del PCI. Resumen Bajo supervisión directa, esta posición puede investigar, escribir, coordinar y revisar desviaciones, acciones correctivas y preventivas, reclamaciones y otros documentos cGMP como Master Production Batch Records. Puede apoyar equipos interfuncionales. Autores y revisar registros de lotes, desviaciones, quejas y otra documentación técnica. Gestiona componentes específicos de desvios a gran escala. Realiza seguimiento y tendencias de la documentación y datos relevantes según lo especificado. Mantiene un entorno GLP/cGMP y sigue SOPs. Ajusta responsabilidades y actividades para satisfacer las expectativas del cliente y internas. Seguir documentos abiertos para garantizar el cierre oportuno de revisiones e investigaciones de los registros por lotes. Proporciona apoyo para auditorías internas y de clientes cuando sea necesario. Familiariza con nuevos equipos, sistemas y tecnologías para crear y mantener una documentación precisa. Asistencia regular y fiable en tiempo completo [o de acuerdo con el horario publicado]. Responsable de mostrar comportamiento profesional tanto interno como externo que refleje positivamente las políticas y prácticas culturales de la compañía y las acciones asociadas. Se requiere un diploma de escuela secundaria o equivalente. 02 años de experiencia relevante en la fabricación. Se prefieren al menos 1 año de experiencia pertinente en un entorno cGMP. Se precisan experiencias previas con investigaciones. Se preferen conocimientos técnicos pertinentes (SOPs, acciones preventivas, desviaciones, etc.). Este puesto tiene la máxima responsabilidad de cumplir con las reglas y regulaciones relativas a un entorno laboral seguro y saludable en relación con sus acciones y conducta. Puede requerirse tareas fuera del turno, durante el fin de semana o horas extras. La tasa de contratación para este puesto es de $19.54$21.98 más la elegibilidad para una bonificación anual de rendimiento. Las cantidades de ofertas finales se determinan por múltiples factores, incluidos pero no limitados a experiencia específica y relevante, educación, credenciales, geografía y conocimientos sobre temas relacionados. PCI ofrece a los empleados de tiempo completo un paquete de beneficios competitivos que incluye vacaciones pagadas, cobertura de seguros médicos (incluyendo salud dental y visión), estatus de gasto flexible y un plan 401k. Únete a nosotros y sea parte de construir el puente entre Equapies e pacientes que cambian su vida. Estamos comprometidos a cultivar un lugar de trabajo inclusivo manteniéndonos responsables de los más altos estándares de comprensión, equidad, respeto y igualdad de oportunidades en todos los niveles. Imaginamos una comunidad PCI donde todo el mundo pueda pertenecer y crecer, y nos esforzamos por hacer realidad esta visión evaluando continuamente e intencionadamente nuestras prácticas personales, políticas y programas, enfoque de marketing y cultura laboral.