41 Sr QA Manager (Document Control & Training) Jobs in Decatur, IL
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Sr QA Manager (Document Control & Training)
$106k-149k (estimate)
Contractor
2 Months Ago
Webologix Global is Hiring a Sr QA Manager (Document Control & Training) Near Decatur, IL
Job Title:- Sr QA Manager (Document Control & Training)
Domain:- Pharmaceuticals/Biotechnology/Clinical Research
Location:- Decatur, Illinois, USA
Salary:- USD 100000 - 120000
Job Description:- Position SummaryThe Senior QA Manager of Document Control and Training will be responsible for the oversight of the documentation and training programs.
This includes but is not limited to: Standard Operating Procedures (SOPs), Specifications, Document Change Requests (DCRs), Master Batch Records (MBRs), Protocols, Training Curriculum, and Quality Management Systems (QMS).
This individual will work in a detail oriented, compliant manner to ensure the facility operates in alignment with Rising policies, procedures, and cGMPs.
Essential Duties & ResponsibilitiesResponsible for the overall direction, coordination, and evaluation of the Document Control and Training departments.
Lead and assist with maintaining the electronic Document Management System (DMS).
Lead and assist with maintaining the electronic Learning Management System (LMS) for training.
Maintain training curricula for positions at the site.
Responsible for organizing and archiving cGMP documents on site.
Compile and report metrics for Quality Assurance Documentation and Training.
Evaluates quality processes for alignment with cGMPs and evolving regulatory expectations.
Assist with investigations and review/approve as needed.
Review all controlled documents through Document Change Request (DCR) process.
Implements and enforces systems, policies, and procedures.
Assist HR with the creation and delivery of New Hire Orientation (NHO).
Assist with audits, both internal and external.
Additional ResponsibilitiesResponsible for performance reviews, goal setting, and personnel development plans for Supervisor, QA Documentation Systems and QA Technicians - Documentation Providing regular performance feedback (praise and developmental) to members of QA Quality Operations team.
Assists in recruiting, interviewing, and hiring qualified employees to fill open positions.
Addressing complaints and resolving personnel problems within the department(s).
Maintaining confidentiality of information.
Education And ExperienceBachelor's Degree from a four-year accredited college or university with Major in a science related field.
Minimum of five years of cGMP quality assurance experience in biotechnology, pharmaceutical, or medical device industry. Working knowledge, writing, and following of SOPs; document management and control system processes.
Job PrerequisitesAll full-time employees are required to work a 40-hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines.
All applicants must be able to meet the attendance standards.
Working knowledge of Microsoft Office Word, Excel, Outlook, and Power Point. Excellent conceptualizing, analytical, and problem-solving skills.
Experience with an Electronic Document Management System. Pharmaceutical industry knowledge strongly preferred.
Physical Demands, Mental Requirements, And Work EnvironmentWhile performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.
The employee is required to use hands to finger, handle, or feel.
Specific vision abilities required by this job include close vision for written work, PC use, and evaluation of test specimens.
Mental RequirementsEffective written and oral communication skills;
Strong organizational, planning, and communication skills;
Ability to apply deductive reasoning and analytical thoughts to understand complicated issues;
Demonstrates exceptional time management skills;
Ability to work in an independent manner, as well as a group environment;
Ability to multi-task, set priorities, meet deadlines and effectively deal with a high level of office stress;
and Ability to maintain confidentiality of work assignments and personnel issues.
Thanks & RegardsVishal TyagiWebologix IncDirect- 1 332529-9840Email – vishal.tyagi@webologix.netwww.webologics.com (Europe/ USA/ UK / Canada)
Domain:- Pharmaceuticals/Biotechnology/Clinical Research
Location:- Decatur, Illinois, USA
Salary:- USD 100000 - 120000
Job Description:- Position SummaryThe Senior QA Manager of Document Control and Training will be responsible for the oversight of the documentation and training programs.
This includes but is not limited to: Standard Operating Procedures (SOPs), Specifications, Document Change Requests (DCRs), Master Batch Records (MBRs), Protocols, Training Curriculum, and Quality Management Systems (QMS).
This individual will work in a detail oriented, compliant manner to ensure the facility operates in alignment with Rising policies, procedures, and cGMPs.
Essential Duties & ResponsibilitiesResponsible for the overall direction, coordination, and evaluation of the Document Control and Training departments.
Lead and assist with maintaining the electronic Document Management System (DMS).
Lead and assist with maintaining the electronic Learning Management System (LMS) for training.
Maintain training curricula for positions at the site.
Responsible for organizing and archiving cGMP documents on site.
Compile and report metrics for Quality Assurance Documentation and Training.
Evaluates quality processes for alignment with cGMPs and evolving regulatory expectations.
Assist with investigations and review/approve as needed.
Review all controlled documents through Document Change Request (DCR) process.
Implements and enforces systems, policies, and procedures.
Assist HR with the creation and delivery of New Hire Orientation (NHO).
Assist with audits, both internal and external.
Additional ResponsibilitiesResponsible for performance reviews, goal setting, and personnel development plans for Supervisor, QA Documentation Systems and QA Technicians - Documentation Providing regular performance feedback (praise and developmental) to members of QA Quality Operations team.
Assists in recruiting, interviewing, and hiring qualified employees to fill open positions.
Addressing complaints and resolving personnel problems within the department(s).
Maintaining confidentiality of information.
Education And ExperienceBachelor's Degree from a four-year accredited college or university with Major in a science related field.
Minimum of five years of cGMP quality assurance experience in biotechnology, pharmaceutical, or medical device industry. Working knowledge, writing, and following of SOPs; document management and control system processes.
Job PrerequisitesAll full-time employees are required to work a 40-hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines.
All applicants must be able to meet the attendance standards.
Working knowledge of Microsoft Office Word, Excel, Outlook, and Power Point. Excellent conceptualizing, analytical, and problem-solving skills.
Experience with an Electronic Document Management System. Pharmaceutical industry knowledge strongly preferred.
Physical Demands, Mental Requirements, And Work EnvironmentWhile performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.
The employee is required to use hands to finger, handle, or feel.
Specific vision abilities required by this job include close vision for written work, PC use, and evaluation of test specimens.
Mental RequirementsEffective written and oral communication skills;
Strong organizational, planning, and communication skills;
Ability to apply deductive reasoning and analytical thoughts to understand complicated issues;
Demonstrates exceptional time management skills;
Ability to work in an independent manner, as well as a group environment;
Ability to multi-task, set priorities, meet deadlines and effectively deal with a high level of office stress;
and Ability to maintain confidentiality of work assignments and personnel issues.
Thanks & RegardsVishal TyagiWebologix IncDirect- 1 332529-9840Email – vishal.tyagi@webologix.netwww.webologics.com (Europe/ USA/ UK / Canada)
Job Summary
JOB TYPE
Contractor
SALARY
$106k-149k (estimate)
POST DATE
05/30/2024
EXPIRATION DATE
11/05/2024
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