PCI Pharma Services is hiring: Manufacturing Investigator I (Batch Record Author
PCI Pharma Services, San Diego, CA, United States
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 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 While performing the duties the employee is:
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
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In Summary: The Manufacturing Investigator I supports simple write-ups and the resolution of issues or risks related to Manufacturing . The position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment . The hiring rate for this position is $19.54 -$21.98 plus eligibility for an annual performance bonus .
En Español: SUMARIO Bajo supervisión directa, esta posición puede investigar, autor, coordinar y revisar desviaciones, acciones correctivas y preventivas, quejas y otros documentos de CGMP como los Registros Maestros de Producción. El Investigador Manufacturero I apoya las escrituras simples y la resolución de problemas o riesgos relacionados con la fabricación. Esta función trabaja con múltiples departamentos, y puede coordinar el examen, revisión y aprobación de procedimientos y documentación asociada. Puede apoyar equipos interfuncionales. Autor y revisar registros de lotes, desviaciones, quejas y otra documentación técnica. Gestiona componentes específicos de las desvias a gran escala. Rastrea y sigue 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 e interna. Sigue documentos abiertos para garantizar el cierre oportuno de revisiones e investigaciones de los registros por lotes. Proporciona apoyo para auditorías internas y de clientes según sea necesario. Se 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 los programas publicados]. Responsable de mostrar comportamiento profesional tanto interno como externo que refleje positivamente sobre las prácticas comerciales y políticas culturales de la compañía y las acciones asociadas al departamento de servicios farmacéuticos DE ECEPERICIONES O Asociados. Se requiere un diploma de escuela secundaria o equivalente. 0-2 años de experiencia relevante en la fabricación. Prefiere el mínimo de 1 año de experiencia pertinente en entorno cGMP. Se prefieren experiencias previas con investigaciones anteriores. se prefiere familiaridad con documentación técnica relevante (SOPs, acciones preventivas, desviaciones, etc.). Esta posición 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 que se requieran deberes fuera del turno, fines de semana y horas extras. * La tasa de contratación para esta posición es de $19.54 - $21.98 más la elegibilidad para una bonificación anual de rendimiento. Los montos de la oferta final son determinados por múltiples factores, incluidos pero no limitados a experiencia específica y relevante, educación, credenciales, geografía y conocimientos sobre el tema. PCI ofrece a los empleados de tiempo completo un paquete de beneficios competitivos que incluye tiempo libre, cobertura de seguros médicos (incluyendo cambio dental y visión), una cuenta de gasto doméstico flexible y un plan 401k. Únete a nosotros y sea parte de construir el puente entre terapias que cambian la vida y pacientes. 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 llevar esta visión a la realidad evaluando continuamente e intencionalmente las prácticas, políticas y programas de nuestra gente, enfoque de marketing y cultura laboral.
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 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 While performing the duties the employee is:
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 . The position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment . The hiring rate for this position is $19.54 -$21.98 plus eligibility for an annual performance bonus .
En Español: SUMARIO Bajo supervisión directa, esta posición puede investigar, autor, coordinar y revisar desviaciones, acciones correctivas y preventivas, quejas y otros documentos de CGMP como los Registros Maestros de Producción. El Investigador Manufacturero I apoya las escrituras simples y la resolución de problemas o riesgos relacionados con la fabricación. Esta función trabaja con múltiples departamentos, y puede coordinar el examen, revisión y aprobación de procedimientos y documentación asociada. Puede apoyar equipos interfuncionales. Autor y revisar registros de lotes, desviaciones, quejas y otra documentación técnica. Gestiona componentes específicos de las desvias a gran escala. Rastrea y sigue 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 e interna. Sigue documentos abiertos para garantizar el cierre oportuno de revisiones e investigaciones de los registros por lotes. Proporciona apoyo para auditorías internas y de clientes según sea necesario. Se 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 los programas publicados]. Responsable de mostrar comportamiento profesional tanto interno como externo que refleje positivamente sobre las prácticas comerciales y políticas culturales de la compañía y las acciones asociadas al departamento de servicios farmacéuticos DE ECEPERICIONES O Asociados. Se requiere un diploma de escuela secundaria o equivalente. 0-2 años de experiencia relevante en la fabricación. Prefiere el mínimo de 1 año de experiencia pertinente en entorno cGMP. Se prefieren experiencias previas con investigaciones anteriores. se prefiere familiaridad con documentación técnica relevante (SOPs, acciones preventivas, desviaciones, etc.). Esta posición 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 que se requieran deberes fuera del turno, fines de semana y horas extras. * La tasa de contratación para esta posición es de $19.54 - $21.98 más la elegibilidad para una bonificación anual de rendimiento. Los montos de la oferta final son determinados por múltiples factores, incluidos pero no limitados a experiencia específica y relevante, educación, credenciales, geografía y conocimientos sobre el tema. PCI ofrece a los empleados de tiempo completo un paquete de beneficios competitivos que incluye tiempo libre, cobertura de seguros médicos (incluyendo cambio dental y visión), una cuenta de gasto doméstico flexible y un plan 401k. Únete a nosotros y sea parte de construir el puente entre terapias que cambian la vida y pacientes. 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 llevar esta visión a la realidad evaluando continuamente e intencionalmente las prácticas, políticas y programas de nuestra gente, enfoque de marketing y cultura laboral.