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Quality Assurance

Spectraforce Andover Full-Time
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QA/QC in MA

This position reviews and approves documentation associated with the supply, receipt, testing and release of raw materials and cell banks used in clinical and commercial manufacturing to ensure timely review and disposition of batches/lots. Accountable for activities involved in the evaluation process of related documents to determine if product specifications are met, ensuring that established sampling and statistical process control procedures are followed, identifying and reviewing deviations from established standards in the manufacturing and/or packaging of products, and reviewing and approving investigations and change control activities to ensure compliance.

 

What we do?

SPECTRAFORCE is an award winning global staffing, IT services and consulting company that specializes in providing top talent and solutions for clients throughout North America and India. We pride ourselves on our partnership with our clients, MSP/VMS providers, and our employees, who have enabled us to continually be ranked as a Top Supplier in the 75+ different clients we support.

 

Job Specifications

  • Performs all work in compliance with cGMPs and site requirements. 
  • Review and approval of GMP documentation and their compliance to Client Quality Standards.
  • Ensure adherence to quality procedures, regulatory requirements and cGMPs. 
  • Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact. 
  • Author, review and edit documents as required such as annual product reviews and certification documents. Actively participate in investigations and compliance related issues.
  • Excellent oral/written communication and presentation skills.

 

Top Skills -Requirement:

We are looking for is someone who has the experience with the following:

·         MD or DO degree from an accredited medical school

·         Completion of residency training program in ABMS/AOA recognized clinical specialty

·         3 years clinical experience after the completion of residency training program is required

·         A current North Carolina Medical License, without restriction.

·         3 years administrative medicine/managed care (utilization and disease management) experience.

·         Knowledge and understanding of appropriate NC and federal legislation

·         Strong people skills and the ability to be resourceful, as well as to make concise, independent and defensible decisions in often high-pressure situations.

·         Proven ability to effectively communicate orally and in writing detailed and complex information to others that possess varying degrees of comprehension.

·         Board certification in primary specialty (ABMS or AOA approved specialty/subspecialty).

 

Why you should apply:

·         Great competitive pay

·         Strongly prefer local candidates but open to non-local candidates those who are willing to relocate

·         Opportunity to work with one of the pharmaceutical giant

·         Great work culture and ability to get exposure of working with a great product line with Fortune 500 Company

 

Application Process:

·         Apply online: Candidates would send updated resumes over the emails on phuntsok.dolma@spectraforce.com OR call us 919-230-9952 (Ext. 4643).

·         Application Submission: we will reach out to you over the phone to discuss important aspects of this job opening and upon agreement your profile will be submitted to the client for review.

·         Interviews: Usually 2 interview process, 1st Telephonic Screening and then followed up by a face to face/video interview. However it depends on the size of the selection committee, there may be additional interviews for each candidate. We will coordinate with candidates to set up interviews with our client.

·         Background checks: After Job offer, background checks would be conducted to review candidates’ criminal record, to verify employment history and eligibility, and to run credit checks. Drug testing may also be warranted, depending on the nature of the job.

·         Onboarding: Based on the background checks, first day reporting details would be shared with candidate upon the client ‘instructions.

·         Job offer: After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on.

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
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Spectraforce offers a powerful suite of Staffing and Outsourcing solutions in Information Technology, Clinical, Technical, Pharmaceutical and Engineering domains allowing companies to embrace the challenges of meeting and exceeding the company's ongoing requirements.

We enable companies to focus on their core competencies, while we handle the integral details of building infrastructure thus guaranteeing quality delivery with major cost savings. We offer a competitive edge through our unique Center of Excellence-based IT outsourcing services powered by our offshore Global Delivery capabilities.

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