Biology Jobs .com Life Science career site  
 
 

Fortira Inc

Quality Control Chemist

Post Date:Apr 24, 2017Type:Full-Time
Start Date:4/21/2017Salary:
Location:US-NC-Rocky Mount Job Reference:
Skills:


Job Title: Quality Control Chemist

Job Location: Rocky Mount, NC 

Duration: 18+ months

 

Job Description:

The Sr. Quality Specialist shall independently conduct and write complex formal investigation reports with input from area SMEs. The candidate will function as an independent reviewer of drafted investigations providing constructive feedback and in some instances act as a coach to the investigator. This position will also perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action. The incumbent will assist in the tracking and trending of corrective and preventative action to assure timely closure. This person will also perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.

 

POSITION RESPONSIBILITIES

In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.

 

•2-5 years experience in pharmaceutical quality environment required

•Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products.

•Working knowledge of environmental monitoring and aseptic manufacturing.

•Understanding of process validation requirements.

•American Society for Quality (ASQ) certification is an asset.

•Pharmaceutical operations experience and/or knowledge. Experience in a solutions facility preferred.

•Working knowledge of FDA regulations.

•Knowledge of various quality tools such as root cause analysis, DMAIC process, fishbone analysis, etc.

•Prior investigation writing experience (with determination of product impact).

•Strong oral and written communication presentation, interpersonal skills and adept at communication with employees at all levels within the organization.

•Excellent facilitation skills and ability to facilitate strategy meetings.

•Superior technical writing and problem solving skills.

•Organize data, extract key information and write technical summary reports.

•Expertise with word-processing, spreadsheet, and presentation software. TrackWise experience a plus.•        

 

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.

•Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.

 

 

EDUCATION AND EXPERIENCE

Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).

•             Bachelor’s degree (science preferred) with 3-5 years experience in the FDA regulated industry.

 

TECHNICAL SKILLS REQUIREMENTS

Indicate the technical skills required and/or preferred, as applicable.

 

Best Regards,

Sravanthi Vanapalli

Talent Acquisition

 

 

4365-US Hwy 1 South, Suite 105, Princeton, NJ 08540

(609) 681-5753 (Off), 609-454-3209 Ext 116 | 609.356.0312 (Fax)

Email: [Click Here to Email Your Resumé]

FORTIRA is a certified Minority Business Enterprise (MBE)






Job Description:


Job Title: Quality Control Chemist

Job Location: Rocky Mount, NC 

Duration: 18+ months

 

Job Description:

The Sr. Quality Specialist shall independently conduct and write complex formal investigation reports with input from area SMEs. The candidate will function as an independent reviewer of drafted investigations providing constructive feedback and in some instances act as a coach to the investigator. This position will also perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action. The incumbent will assist in the tracking and trending of corrective and preventative action to assure timely closure. This person will also perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.

 

POSITION RESPONSIBILITIES

In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.

 

•2-5 years experience in pharmaceutical quality environment required

•Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products.

•Working knowledge of environmental monitoring and aseptic manufacturing.

•Understanding of process validation requirements.

•American Society for Quality (ASQ) certification is an asset.

•Pharmaceutical operations experience and/or knowledge. Experience in a solutions facility preferred.

•Working knowledge of FDA regulations.

•Knowledge of various quality tools such as root cause analysis, DMAIC process, fishbone analysis, etc.

•Prior investigation writing experience (with determination of product impact).

•Strong oral and written communication presentation, interpersonal skills and adept at communication with employees at all levels within the organization.

•Excellent facilitation skills and ability to facilitate strategy meetings.

•Superior technical writing and problem solving skills.

•Organize data, extract key information and write technical summary reports.

•Expertise with word-processing, spreadsheet, and presentation software. TrackWise experience a plus.•        

 

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.

•Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.

 

 

EDUCATION AND EXPERIENCE

Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).

•             Bachelor’s degree (science preferred) with 3-5 years experience in the FDA regulated industry.

 

TECHNICAL SKILLS REQUIREMENTS

Indicate the technical skills required and/or preferred, as applicable.

 

Best Regards,

Sravanthi Vanapalli

Talent Acquisition

 

 

4365-US Hwy 1 South, Suite 105, Princeton, NJ 08540

(609) 681-5753 (Off), 609-454-3209 Ext 11| 609.356.0312 (Fax)

Email: [Click Here to Email Your Resumé]

FORTIRA is a certified Minority Business Enterprise (MBE)







Contact Information
Fortira Inc
Name: Sravanthi Vanapalli
Ph: 609-454-3209 ex 116


Apply for this Job


 
Please help us spread the word about BiologyJobs.com by telling any organization you know that hires employees with a background in biology that they can advertise their open positions online at BiologyJobs.com for only $1 per day with unlimited job postings and resume database access plus their organization's profile and logo featured online. You can't beat the affordable advertising rates of Biology Jobs .com combined with the highly tartgeted traffic that your job postings will recieve compared to other online job board services.

Whether you are working on your degree, or your have completed your B.A. (bachelor of arts) B.S. ( bachelor of science ) M.S.( master of science ), M.A. ( master of arts ),or Ph.D ( doctorate of philosophy ) degree , and you are looking for a postdoctoral ( postdoc ) job, Biology Jobs .com has job openings posted online at various times for all levels of Biology Jobs from volunteer positions to postdoctoral research jobs to tenured professors, positions with top biotechnology companies and everything in between.