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Quality Specialist - II (Associate)

Ascent

Job Description

Quality Specialist - II (Associate)
Elkton, VA 


Specific responsibilities include but are not limited to the following:
• Performs 100% audit of process documents / log books to ensure completeness and accuracy for assigned End to End (E2E). Maintains any tracking databases and logs associated with this review. Coordinates with Production to discuss, resolve, and eliminate documentation observations.
• Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
• Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
• Prioritizes review of process documents / log books in order to maximize cycle-time efficiency.
• Performs SAP transactions required to document Batch Record review.

Qualifications: 
Education:
• Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.
Required Experience and Skills:
• At least one year of relevant post-degree work experience in a laboratory, manufacturing, or quality position.
• Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Preferred Experience and Skills:
• Familiarity with vaccine and/or pharmaceutical processing.
• Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
• Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial.
• Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.

Job Requirements

 
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Job Snapshot

Location US-VA-Elkton
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Other

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Terms & Conditions
Snapshot
Ascent
Company:
US-VA-Elkton
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

Quality Specialist - II (Associate)
Elkton, VA 


Specific responsibilities include but are not limited to the following:
• Performs 100% audit of process documents / log books to ensure completeness and accuracy for assigned End to End (E2E). Maintains any tracking databases and logs associated with this review. Coordinates with Production to discuss, resolve, and eliminate documentation observations.
• Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
• Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
• Prioritizes review of process documents / log books in order to maximize cycle-time efficiency.
• Performs SAP transactions required to document Batch Record review.

Qualifications: 
Education:
• Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.
Required Experience and Skills:
• At least one year of relevant post-degree work experience in a laboratory, manufacturing, or quality position.
• Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Preferred Experience and Skills:
• Familiarity with vaccine and/or pharmaceutical processing.
• Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
• Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial.
• Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.

Job Requirements

 
Quality Specialist - II (Associate) Apply now