Hispanic Alliance for Career Enhancement
Spclst, Quality Systems & Compliance
Hispanic Alliance for Career Enhancement, Lansdale, Pennsylvania, United States, 19446
Job Description
Title: Specialist, Analytical Metrology & Validation, Global Quality Large Molecule Analytical Science The Global Quality Large Molecule Analytical Science (GQLMAS) department of our Manufacturing Division is seeking applicants for a specialist to support metrology and validation team at the West Point and North Wales, PA facility. The Analytical Metrology & Validation specialist will work as part of the GQLMAS and drive a culture of quality and operational excellence across the West Point and North Wales labs. This role requires working with a team of metrology and equipment coordination supporting the maintenance and qualification of analytical equipment and instrumentation within GMP and non?GMP environments. Key Responsibilities Manage equipment assets at multiple locations Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or communicate with the vendor/service engineer to identify resolutions Participate in computer system validation activities associated with new or upgraded equipment or software packages Originate and progress Deviations and Change Control records Perform and document investigations and assist in developing and implementing CAPA plans Contribute to new SOP drafting, implementation, and revisions Represent the laboratory on all aspects of laboratory equipment during audits Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures Maintain a customer?focused mindset and communicate adequately (verbally/writing) to all levels within the organization Upskill quickly in our facilities/instrument support programs (SAP, ProCal, BAS, LAMP, Electronic Validation) and other document/asset repositories Initiate, process, and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment
Calibration Focus
Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation Coordinate service activities across vendors and service engineers while building and maintaining strong working relationships Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross?training and cross?site support Support the purchase, installation, and equipment qualification of new laboratory equipment
Validation Focus
Support primarily the qualification/validation of computerized analytical systems as per current guidelines Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers Perform any required change control during the life cycle of a computerized system Decommission systems as required as part of the equipment qualification/validation life cycle Manage the capital purchasing and initial installation of computerized analytical systems prior to validation Participate in various data integrity and lab modernization activities as required Possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus) Have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system
Education Minimum Requirements
Bachelor's degree in biological or chemical science and/or engineering plus 4+ years of experience participating in the validation of computerized laboratory systems or instruments (e.g., system Installation and Operational qualification) MS with 1 year of experience (or equivalent)
Required Experience and Skills
Perform and direct team validation activities as an independent author Highly skilled in operating analytical computerized instrumentation within a pharmaceutical or equivalent laboratory Collaborate independently with various project teams and execute tasks efficiently
Required Skills
Aseptic Manufacturing, Aseptic Manufacturing, Auditing, Batch Record Review, Calibration Management Software, Calibration Procedures, Consulting, Consumer Relations, Corrective Action Management, Data Analysis, Data Integrity, Decommissioning, FDA Compliance, Financial Advising, Financial Forecasting, GMP Compliance, Good Manufacturing Practices (GMP), GxP Validation, Laboratory Testing, Manufacturing Compliance, Metrology Equipment, Personal Initiative, Policy Development, Quality Control (QC), Quality Improvement Programs Preferred Skills
Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. U.S. Hybrid Work Model
Effective September 5, 2023, employees in office?based positions in the U.S. will be working a Hybrid work consisting of three total days on?site per week, Monday Thursday, although the specific days may vary by site or organization, with Friday designated as a remote?working day, unless business critical tasks require an on?site presence. This Hybrid work model does not apply to field?based positions; facility?based, manufacturing?based, or research?based positions where the work to be performed is located at a Company site; positions covered by a collective?bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote. Salary
Salary range: $85,600.00 $134,800.00 Benefits
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. Application
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Equal Employment Opportunity Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, Learn more about your rights, including under California, Colorado and other U.S. State Acts. San Francisco Residents Only
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr
Title: Specialist, Analytical Metrology & Validation, Global Quality Large Molecule Analytical Science The Global Quality Large Molecule Analytical Science (GQLMAS) department of our Manufacturing Division is seeking applicants for a specialist to support metrology and validation team at the West Point and North Wales, PA facility. The Analytical Metrology & Validation specialist will work as part of the GQLMAS and drive a culture of quality and operational excellence across the West Point and North Wales labs. This role requires working with a team of metrology and equipment coordination supporting the maintenance and qualification of analytical equipment and instrumentation within GMP and non?GMP environments. Key Responsibilities Manage equipment assets at multiple locations Gain a working knowledge of laboratory equipment to facilitate troubleshooting and/or communicate with the vendor/service engineer to identify resolutions Participate in computer system validation activities associated with new or upgraded equipment or software packages Originate and progress Deviations and Change Control records Perform and document investigations and assist in developing and implementing CAPA plans Contribute to new SOP drafting, implementation, and revisions Represent the laboratory on all aspects of laboratory equipment during audits Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures Maintain a customer?focused mindset and communicate adequately (verbally/writing) to all levels within the organization Upskill quickly in our facilities/instrument support programs (SAP, ProCal, BAS, LAMP, Electronic Validation) and other document/asset repositories Initiate, process, and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment
Calibration Focus
Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation Coordinate service activities across vendors and service engineers while building and maintaining strong working relationships Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross?training and cross?site support Support the purchase, installation, and equipment qualification of new laboratory equipment
Validation Focus
Support primarily the qualification/validation of computerized analytical systems as per current guidelines Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers Perform any required change control during the life cycle of a computerized system Decommission systems as required as part of the equipment qualification/validation life cycle Manage the capital purchasing and initial installation of computerized analytical systems prior to validation Participate in various data integrity and lab modernization activities as required Possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus) Have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system
Education Minimum Requirements
Bachelor's degree in biological or chemical science and/or engineering plus 4+ years of experience participating in the validation of computerized laboratory systems or instruments (e.g., system Installation and Operational qualification) MS with 1 year of experience (or equivalent)
Required Experience and Skills
Perform and direct team validation activities as an independent author Highly skilled in operating analytical computerized instrumentation within a pharmaceutical or equivalent laboratory Collaborate independently with various project teams and execute tasks efficiently
Required Skills
Aseptic Manufacturing, Aseptic Manufacturing, Auditing, Batch Record Review, Calibration Management Software, Calibration Procedures, Consulting, Consumer Relations, Corrective Action Management, Data Analysis, Data Integrity, Decommissioning, FDA Compliance, Financial Advising, Financial Forecasting, GMP Compliance, Good Manufacturing Practices (GMP), GxP Validation, Laboratory Testing, Manufacturing Compliance, Metrology Equipment, Personal Initiative, Policy Development, Quality Control (QC), Quality Improvement Programs Preferred Skills
Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. U.S. Hybrid Work Model
Effective September 5, 2023, employees in office?based positions in the U.S. will be working a Hybrid work consisting of three total days on?site per week, Monday Thursday, although the specific days may vary by site or organization, with Friday designated as a remote?working day, unless business critical tasks require an on?site presence. This Hybrid work model does not apply to field?based positions; facility?based, manufacturing?based, or research?based positions where the work to be performed is located at a Company site; positions covered by a collective?bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote. Salary
Salary range: $85,600.00 $134,800.00 Benefits
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. Application
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Equal Employment Opportunity Statement
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, Learn more about your rights, including under California, Colorado and other U.S. State Acts. San Francisco Residents Only
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. #J-18808-Ljbffr