Location
Type
Status
Open
McPherson, KS
Full Job Description
ROLE SUMMARY
The MQ Auditor is the primary quality contact for production personnel. This role will monitor production processes for compliance to cGMP standards. Auditors perform and document the testing and inspection results to support product disposition and decisions based on inspection outcomes. Performs multiple functions and makes decisions in support of production processes. Ensures quality of finished product through sampling, testing and evaluation of drug products, as well as accuracy and completeness of batch record and audit documentation.
ROLE RESPONSIBILITIES
Audit compliance of product and processes against governing documents.
Obtain a representative number of samples for visual inspection, physical testing (where applicable), retains and stability studies.
Inspect and verify critical product labeling information for accuracy to ANSI AQL Z.14 standards.
Manage multiple priorities and effectively communicate priorities to interdepartmental partners.
Perform calibration of tools used for inspection activities.
Use critical thinking and problem-solving skills to identify and correct situations which would create delays and/or downtime of equipment.
Perform review of environmental conditions for controlled areas.
Act with ownership and make quality decisions.
Obtain certification as a controlled drug agent (CDA).
Identify and initiate deviation process in areas of expertise
Act as a subject matter expert during health authority inspections.
Adhere to all safety and health practices and procedures.
BASIC QUALIFICATIONS
High school diploma with a minimum of 1+ years of related experience in a regulated industry with the knowledge to provide guidance on quality-related topics.
Knowledge of FDA regulations, specifically cGMPs.
Computer skills (Microsoft Office, Excel)
Excellent organizational, interpersonal, and communication skills (oral and written).
Proven ability to make decisions and work with minimum supervision.
Decision-making and problem-solving abilities
Preferred Qualifications
Previous QA or QC experience in a regulated industry
Previous experience in a field that requires priority on detail management in a self-regulated work environment.
Pharmaceutical or manufacturing, medical office, pharmacy, banking, or purchasing are preferred experiences.
Knowledge of specialized processes that require attention to detail such as basic accounting, operation of equipment, basic computer operations or bookkeeping software.
Previous experience in controlled records documentation.
Full Job Description
ROLE SUMMARY
The MQ Auditor is the primary quality contact for production personnel. This role will monitor production processes for compliance to cGMP standards. Auditors perform and document the testing and inspection results to support product disposition and decisions based on inspection outcomes. Performs multiple functions and makes decisions in support of production processes. Ensures quality of finished product through sampling, testing and evaluation of drug products, as well as accuracy and completeness of batch record and audit documentation.
ROLE RESPONSIBILITIES
Audit compliance of product and processes against governing documents.
Obtain a representative number of samples for visual inspection, physical testing (where applicable), retains and stability studies.
Inspect and verify critical product labeling information for accuracy to ANSI AQL Z.14 standards.
Manage multiple priorities and effectively communicate priorities to interdepartmental partners.
Perform calibration of tools used for inspection activities.
Use critical thinking and problem-solving skills to identify and correct situations which would create delays and/or downtime of equipment.
Perform review of environmental conditions for controlled areas.
Act with ownership and make quality decisions.
Obtain certification as a controlled drug agent (CDA).
Identify and initiate deviation process in areas of expertise
Act as a subject matter expert during health authority inspections.
Adhere to all safety and health practices and procedures.
BASIC QUALIFICATIONS
High school diploma with a minimum of 1+ years of related experience in a regulated industry with the knowledge to provide guidance on quality-related topics.
Knowledge of FDA regulations, specifically cGMPs.
Computer skills (Microsoft Office, Excel)
Excellent organizational, interpersonal, and communication skills (oral and written).
Proven ability to make decisions and work with minimum supervision.
Decision-making and problem-solving abilities
Preferred Qualifications
Previous QA or QC experience in a regulated industry
Previous experience in a field that requires priority on detail management in a self-regulated work environment.
Pharmaceutical or manufacturing, medical office, pharmacy, banking, or purchasing are preferred experiences.
Knowledge of specialized processes that require attention to detail such as basic accounting, operation of equipment, basic computer operations or bookkeeping software.
Previous experience in controlled records documentation.
McPherson, KS
Full Job Description
ROLE SUMMARY
The MQ Auditor is the primary quality contact for production personnel. This role will monitor production processes for compliance to cGMP standards. Auditors perform and document the testing and inspection results to support product disposition and decisions based on inspection outcomes. Performs multiple functions and makes decisions in support of production processes. Ensures quality of finished product through sampling, testing and evaluation of drug products, as well as accuracy and completeness of batch record and audit documentation.
ROLE RESPONSIBILITIES
Audit compliance of product and processes against governing documents.
Obtain a representative number of samples for visual inspection, physical testing (where applicable), retains and stability studies.
Inspect and verify critical product labeling information for accuracy to ANSI AQL Z.14 standards.
Manage multiple priorities and effectively communicate priorities to interdepartmental partners.
Perform calibration of tools used for inspection activities.
Use critical thinking and problem-solving skills to identify and correct situations which would create delays and/or downtime of equipment.
Perform review of environmental conditions for controlled areas.
Act with ownership and make quality decisions.
Obtain certification as a controlled drug agent (CDA).
Identify and initiate deviation process in areas of expertise
Act as a subject matter expert during health authority inspections.
Adhere to all safety and health practices and procedures.
BASIC QUALIFICATIONS
High school diploma with a minimum of 1+ years of related experience in a regulated industry with the knowledge to provide guidance on quality-related topics.
Knowledge of FDA regulations, specifically cGMPs.
Computer skills (Microsoft Office, Excel)
Excellent organizational, interpersonal, and communication skills (oral and written).
Proven ability to make decisions and work with minimum supervision.
Decision-making and problem-solving abilities
Preferred Qualifications
Previous QA or QC experience in a regulated industry
Previous experience in a field that requires priority on detail management in a self-regulated work environment.
Pharmaceutical or manufacturing, medical office, pharmacy, banking, or purchasing are preferred experiences.
Knowledge of specialized processes that require attention to detail such as basic accounting, operation of equipment, basic computer operations or bookkeeping software.
Previous experience in controlled records documentation.
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