Font Size:  
Contrast:  

Job Details

This job opportunity is no longer available.

This page has been archived for your reference. You can try to continue to this position on the employer's website or try a new search. Inquiries related to this position should be directed to the employer.

Operations Compliance Improvement Lead (Overnight Shift) - St. Louis, MO

GlaxoSmithKline
St. Louis, MO
View GlaxoSmithKline Company Profile

Description

Basic qualifications:
• High School Diploma / GED
• Minimum of 3 years of experience in a regulated production facility.  
• Proficient with MS Word and Excel.
• Technical understanding of equipment in a Manufacturing environment
• Good knowledge of cGMPs.
• Able to manage their time and complete projects on time.


Preferred qualifications:
• BS Degree in Science, Engineering, or related field.
• Experience in a leadership role in a regulated production facility is preferred.
• Proficient with Trackwise preferred.


Details:
The Operations Compliance Improvement Lead will support the deviation management for the Operations Departments (Manufacturing and Packaging).  To ensure that Operations Departments (Manufacturing and Packaging) remain compliant and up to date on audits, CAPA and CAPA effectiveness.

PLEASE NOTE: The hours for this position are 10:30pm -7am.

Key Responsibilities:
• To initiate deviations with relevant problem statements and appropriate attachments to support the site deviation management process.
• To investigate deviations using RCA tools such as fishbone and 5 why analysis and write compliant deviations to pharmaceutical standards.
• To assist the manufacturing and packaging departments with production issues as required.
• To update / create procedures and/or forms as required.
• To run metrics and ensure all CAPA for the manufacturing and packaging departments are completed accurately and on time.
• To develop a process to ensure CAPAs are effective.
• To carry out a periodic review of the CAPA for the departments and present that information to the Operations Support Manager and Department Managers.
• To support the sites Level 1 and Level 2 audits as necessary.


Contact information:
You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

Details:

  • JobId: WD138283
  • Posted / Updated: 9/13/2017

Map