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Title : MKG- Quality Specialist II -938
State : Virginia   Date : Sep 23, 2020
Experience Level :  
Position Type : Quality Specialist II      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Elkton, VA

Job Title: Quality Specialist II 

Duration: 6+ months (extendable) contract on W2


Duties: 

The Specialist Quality Assurance, with guidance from the Quality Assurance Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. He/she is responsible for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines. The Specialist Quality Assurance position requires strong quality/analytical/scientific skills, as well as leadership abilities in order to manage Quality Operations within their team. Strong collaboration, communication, and decision making are attributes. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence. 

Primary Activities: 

1. Acts as a Quality contact for their area of support. As such, he/she must have sound knowledge of process, GMP systems, regulatory guidelines, design standards, company policies, as well as local SOPs . He/she is accountable for the shared operations, quality and technology objectives for their area, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time. Aids in coordination and execution of Quality Operations activities to ensure production plans are met, utilizing the tier process. Supports project work in the building. 
2. Performs review and approval for investigations, CAPAs, QCTS commitments, change requests, risks, IQ/OQ/PQ, validation, Master Batch Records (MBRs), etc. 
3. Performs GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements. 
4. Actively participates in site inspections/audits by fulfilling requests for information. 
5. Review, approve SOPs and other instructional documents for shop floor. 
7. Provides training to incoming personnel and ensures compliance with departmental procedures. A day in the life of: 80% of the role is reviewing batch records to support release of batches. 20% will be walking on shop floor performing audits/document review and interacting with staff who are running process. Shop floor process is antibiotic powder Aseptic processing. 

The Quality group is responsible for a certain number of audits. This resource will work to observe team doing job, noting housekeeping cGMP and GMP process'. Also, on the floor, real time document review will be taking place, in addition to signing for all steps that have been executed. The quality team is responsible for running 4 different process' while on the shop floor. This candidate will be interacting with all 7 team members on any given day. As most work is remote, there is currently an every day Morning quality check in meeting as well as a bi weekly staff meeting.

Qualifications: 

Education Minimum Requirement: 
Bachelor’s degree required - concentration in Chemistry, Chemical Engineering, life sciences, Pharmacy, Biology, Microbiology, or equivalent preferred. 

Required Experience and Skills: 
Experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including regulatory requirements. 

Preferred Experience and Skills: 
Strong knowledge of Pharmaceutical Manufacturing, SAP ECC, TrackWise and project management. Supervisory and management experience a plus. Additional qualifications: Basic to intermediate computer skills including Microsoft office suite, Time management and organization. Previous experience in a beta lactum environment, working with antibiotics/Aseptic processing. Min of 3-5 years of experience min with managing people. Previous experience in regulated background such as FDA. cGMP & GMP experience. In addition, cross functional team experience. 

Manager will be looking for examples of the following during the interview - how well a candidate describes teamwork, an individual who is an independent worker and requires little oversight. Good Decision making, problem solving. Personality Type: Not afraid to speak up when they don't understand something or something doesn't seem right. Someone who has good leadership abilities. Initiative and drive. Gets along with others. Receptive to feedback, negative or positive. 3-5 years of experience min with managing people. Resume red flags - Large gaps on a resume, very short tenure at several different companies. Looking for position stability.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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