PharmaLex
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Specialist QA
role at
PharmaLex
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Responsibilities
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Shift Shift:
Administrative
Location Location:
Juncos, PR
Education Education:
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Preferred Qualifications Experience with NPI, Change Control, FATs, Validation, and PPQs
Skills
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Values/Leadership Practices.
Benefits We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. For details, visit
https://www.virtualfairhub.com/cencora .
Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. All hiring processes comply with non‑discriminatory principles, and the company provides reasonable accommodations for individuals with disabilities during the employment process.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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Specialist QA
role at
PharmaLex
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Responsibilities
Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Shift Shift:
Administrative
Location Location:
Juncos, PR
Education Education:
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Preferred Qualifications Experience with NPI, Change Control, FATs, Validation, and PPQs
Skills
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Values/Leadership Practices.
Benefits We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. For details, visit
https://www.virtualfairhub.com/cencora .
Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. All hiring processes comply with non‑discriminatory principles, and the company provides reasonable accommodations for individuals with disabilities during the employment process.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr