The Change Control Group provides support to other departments as needed and is critical in ... Demonstrated analytical and critical thinking skills. * Knowledge of applicable FDA regulations and ...
The Change Control Group provides support to other departments as needed and is critical in ... Demonstrated analytical and critical thinking skills. * Knowledge of applicable FDA regulations and ...
QC Analyst III, Analytical - LSA
Portsmouth, NH · On-site
$70 - $90/hr
QC Analyst III, Analytical - Large Scale Allogenic Manufacturing United States, Portsmouth (New ... CAPA & Change Control Management Author, edit, and coordinate corrective and preventive actions ...
QC Analyst III, Analytical - LSA
Portsmouth, NH · On-site
$70 - $90/hr
QC Analyst III, Analytical - Large Scale Allogenic Manufacturing United States, Portsmouth (New ... CAPA & Change Control Management Author, edit, and coordinate corrective and preventive actions ...
Have strong analytical and problem solving skills. * Conduct periodic reconciliation reviews of ... Change Control Specialist shall have consecutive employment in a position with comparable ...
Have strong analytical and problem solving skills. * Conduct periodic reconciliation reviews of ... Change Control Specialist shall have consecutive employment in a position with comparable ...
QC Analyst II, Analytical - LSA
Portsmouth, NH · On-site
$24.50 - $32.75/hr
QC Analyst II, Analytical - Large Scale Allogenic Manufacturing Location: Portsmouth, NH, USA ... CAPA & Change Control Management: Author, edit, and coordinate corrective and preventive actions ...
QC Analyst II, Analytical - LSA
Portsmouth, NH · On-site
$24.50 - $32.75/hr
QC Analyst II, Analytical - Large Scale Allogenic Manufacturing Location: Portsmouth, NH, USA ... CAPA & Change Control Management: Author, edit, and coordinate corrective and preventive actions ...
Project Control Analyst
Chantilly, VA · On-site
$69 - $158/hr
The right mixture of great ideas and funding can create change. In a complex organization ... As a Project Control Analyst on our team, you will be responsible for a wide variety of detailed ...
Project Control Analyst
Chantilly, VA · On-site
$69 - $158/hr
The right mixture of great ideas and funding can create change. In a complex organization ... As a Project Control Analyst on our team, you will be responsible for a wide variety of detailed ...
QC Analyst II, Analytical - LSA
Portsmouth, NH · On-site
$24.50 - $32.75/hr
QC Analyst II, Analytical - Large Scale Allogenic Manufacturing Location: Portsmouth, NH, USA ... CAPA & Change Control Management: Author, edit, and coordinate corrective and preventive actions ...
QC Analyst II, Analytical - LSA
Portsmouth, NH · On-site
$24.50 - $32.75/hr
QC Analyst II, Analytical - Large Scale Allogenic Manufacturing Location: Portsmouth, NH, USA ... CAPA & Change Control Management: Author, edit, and coordinate corrective and preventive actions ...
QC Analyst I
Vacaville, CA · On-site
$20 - $25/hr
Job Title: QC Analyst Location: Vacaville, CA Duration: 6 months Job Type: Temporary Position Work ... Manage change control documentation * Handle data table requests and annual report requests ...
Quick apply
QC Analyst I
Vacaville, CA · On-site
$20 - $25/hr
Job Title: QC Analyst Location: Vacaville, CA Duration: 6 months Job Type: Temporary Position Work ... Manage change control documentation * Handle data table requests and annual report requests ...
QC Analyst III - Portsmouth, NH
Portsmouth, NH · On-site
$24.50 - $32.75/hr
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control ... Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods. * Projects - such as ...
Quick apply
QC Analyst III - Portsmouth, NH
Portsmouth, NH · On-site
$24.50 - $32.75/hr
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control ... Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods. * Projects - such as ...
QC Analyst III
Portsmouth, NH · On-site
$33/hr
Job Title: QC Analyst III Location: Portsmouth, NH - 100% On-Site Pay Rate: $33.00/hour We're ... Author Deviations, CAPA, Change Controls, and Test Methods. * Train peers on QC processes and ...
Quick apply
QC Analyst III
Portsmouth, NH · On-site
$33/hr
Job Title: QC Analyst III Location: Portsmouth, NH - 100% On-Site Pay Rate: $33.00/hour We're ... Author Deviations, CAPA, Change Controls, and Test Methods. * Train peers on QC processes and ...
Quality Control Analyst
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. Skills in ...
Quality Control Analyst
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. Skills in ...
QC Analyst III
Portsmouth, NH · On-site
$25 - $30/hr
Job Title: QC Analyst III Location: Portsmouth, NH 03801 Duration: 12 months Job Type: Temporary ... Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods * Projects - such as ...
Quick apply
QC Analyst III
Portsmouth, NH · On-site
$25 - $30/hr
Job Title: QC Analyst III Location: Portsmouth, NH 03801 Duration: 12 months Job Type: Temporary ... Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods * Projects - such as ...
Quality Control Analyst
Monroe, NC · On-site
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. Skills in ...
Quality Control Analyst
Monroe, NC · On-site
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. Skills in ...
Quality Control Analyst
Bridgewater, NJ · On-site
$90K - $210K/yr
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc ... reviewing applications, analyzing resumes, or assessing responses and identifying potential ...
Quality Control Analyst
Bridgewater, NJ · On-site
$90K - $210K/yr
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc ... reviewing applications, analyzing resumes, or assessing responses and identifying potential ...
Senior Quality Control Analyst
Monroe, NC · On-site
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. * Skills in ...
New
Senior Quality Control Analyst
Monroe, NC · On-site
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. * Skills in ...
New
Quality Control Analyst
Bridgewater, NJ · On-site
$90K - $210K/yr
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc ... reviewing applications, analyzing resumes, or assessing responses and identifying potential ...
Quick apply
Quality Control Analyst
Bridgewater, NJ · On-site
$90K - $210K/yr
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc ... reviewing applications, analyzing resumes, or assessing responses and identifying potential ...
Senior Quality Control Analyst
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. * Skills in ...
New
Senior Quality Control Analyst
$22.25 - $30/hr
Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in ... versed with Change control/deviations and market compliant management system. * Skills in ...
New
Quality Control Analyst
Bridgewater, NJ · On-site
$90K - $210K/yr
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc ... reviewing applications, analyzing resumes, or assessing responses and identifying potential ...
Quality Control Analyst
Bridgewater, NJ · On-site
$90K - $210K/yr
Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc ... reviewing applications, analyzing resumes, or assessing responses and identifying potential ...
Project Control Analyst
Herndon, VA · On-site
Our client is looking for an experienced Project Control Analyst to join their Program Finance ... change control. * Assist in the development of Work Breakdown Structures (WBS) and related ...
Project Control Analyst
Herndon, VA · On-site
Our client is looking for an experienced Project Control Analyst to join their Program Finance ... change control. * Assist in the development of Work Breakdown Structures (WBS) and related ...
Quality Control Analyst III/IV
Seattle, WA · On-site
$27.25 - $36.75/hr
Perform general activities in accordance to SOPs and laboratory quality systems, including change ... Quality Control Analyst III: * BS/MS in a biological science or equivalent level of expereince.
Quality Control Analyst III/IV
Seattle, WA · On-site
$27.25 - $36.75/hr
Perform general activities in accordance to SOPs and laboratory quality systems, including change ... Quality Control Analyst III: * BS/MS in a biological science or equivalent level of expereince.
Program Control Analyst
Huntsville, AL · On-site
We are seeking a Program Control Analyst (PC) to support the planning, tracking, analysis, and ... Purchase Requisitions and Change Order Experience * System and Process automation and documentation ...
Program Control Analyst
Huntsville, AL · On-site
We are seeking a Program Control Analyst (PC) to support the planning, tracking, analysis, and ... Purchase Requisitions and Change Order Experience * System and Process automation and documentation ...
Change Control Analyst information
See salary details
$23.56 - $25.24
5% of jobs
$25.24 - $26.92
12% of jobs
$28.40 is the 25th percentile. Wages below this are outliers.
$26.92 - $28.61
9% of jobs
$28.61 - $30.29
1% of jobs
$30.29 - $31.97
1% of jobs
$31.97 - $33.65
0% of jobs
$33.65 - $35.34
4% of jobs
$35.34 - $37.02
4% of jobs
$37.02 - $38.70
1% of jobs
The median wage is $39.63 / hr.
$38.70 - $40.38
22% of jobs
$41.02 is the 75th percentile. Wages above this are outliers.
$40.38 - $42.07
40% of jobs
$23
$36
$42
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States with the most job openings for Change Control Analyst jobs include:
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Full-time
Posted 16 days ago
American Regent rating
7.2
Based on 12 frontline employees who took The Breakroom Quiz
70th of 86 rated pharmaceutical
Job description
This position is a member of the Change Control Group and is responsible for implementation of processes and/or changes related to the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Change Control Group provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. The QA Change Control Specialist will participate in all aspects of the Change Control Process. This includes all elements of the change lifecycle such as initiation, assisting all participants, and hand-offs to implementation as per applicable Standard Operating Procedures. The level II position requires an individual to perform tasks autonomously with anticipated lead roles for the detailed responsibilities below. There is minimal direct supervision.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- Responsible for the review and approval of change controls, as designee, related to new processes, equipment, material, supplier changes in addition to revisions of documents and creation of new documents.
- Assessing the adequacy of submitted change controls.
- Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes.
- Assist users with the electronic document management system for the site. Tasks include training new personnel on the use of the system, and coordinating with GxP and service provider to resolve system issues.
- Assessing document drafts for format and content in relation to stated change(s).
- Preparing monthly departmental metrics related to change control and document control processes.
- Preparing product specific change control reviews for Annual Product Review assessments.
- Ensuring the appropriate versions of documents are readily accessible in electronic and/or hard copy form.
- Develop, maintain, and facilitate applicable training around the Change Control process and functions. Support preparation of controlled documents through the change control process including proofreading, tracking, and management through completion.
- Collaborate and interact with functional areas within the business (Operations, Quality Control, Research & Development etc.).
- Work independently and is able to recognize daily needs with minimal supervision while delivering timely results.
- Effectively manage multiple tasks while working under pressure.
- Providing support for regulatory inspections including tracking inspection requests, retrieving and copying requested documents, and contacting subject matter experts as needed.
- Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.
- Able to independently problem solve, provide investigation support, and support the change management function.
- Able to develop and revise Standard Operating Procedures related to the Change Control process.
- Establish and maintain quality metrics related to the Change Control process.
- Take ownership of continuous improvement initiatives to improve the Change Control process.
- Able to provide post-implementation support to all stakeholders and Document Control group.
- Perform any other tasks/duties as assigned by management.
- We all must embrace the QUALITY culture.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Bachelor's Degree required in science related discipline strongly preferred.
- Minimum 3 years experience in Quality Assurance function or related field required.
- Advanced computer skills to include Microsoft Word, Excel, Access, Visio or comparable software, PowerPoint, email.
- Demonstrated analytical and critical thinking skills.
- Knowledge of applicable FDA regulations and established expertise in interpreting and applying to the organization required preferred.
- Excellent organizational, interpersonal and communication skills (written and oral) required.
- Ability to take feedback constructively and function in a team oriented work environment.
- Ability to work overtime as needed.
Physical Environment and Requirements
- While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
- Ability to work in an office environment including extensive computer activity.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We're aware of individuals impersonating our staff to target job seekers. Please note:
• All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
• Our recruiting process includes multiple in person and/or video interviews and assessments.
• If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
• We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
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About American Regent
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Shirley, NY, US
Year founded
1910