Quality Assurance Manager - Validation


Groton, Connecticut

7 days ago

Similar Jobs

Job Description

Job Title: Quality Assurance Manager - Validation
Duration: 12 Months
Location: Groton, CT, 06340
This is an onsite role with a Monday - Friday, 1st Shift schedule.

Job Description:
As a Quality Assurance Manager – Validation, the successful candidate will play an integral part in the QA oversight of Validation and Qualification activities conducted within the Client's Groton, CT site.

Role Responsibilities:
  • Provide validation and qualification guidance to customers for equipment and computerized systems related to solid dosage manufacturing, API manufacturing, laboratory instrumentation and related utilities (e.g., water, nitrogen, etc.).
  • Review and approval of validation system life cycle documents including Validation Plans, IQ/OQ/PQ, vendor assessments, design documents, reports, procedures and periodic reviews. Quality lead on large projects and contributes to validation strategy.
  • Participate and/or lead quality investigations including root cause analysis, Clients Human Performance assessments, and approval of investigation reports.
  • Review and approve change controls, quality investigations, and corrective/preventive actions.
  • Participate in the development of procedures which increase efficiency while maintaining high quality standards
  • Provide support to internal audits (e.g. MSQA) & regulatory inspections (e.g. FDA, MHRA) as needed.
  • Participate on special projects, teams and global initiatives.
Basic Qualifications:
  • Bachelor’s Degree (B.S.) with 3-5 years of technical/scientific/pharmaceutical experience/Engineering or equivalent.
  • Must have 3-5 years of relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.
Preferred Qualifications:
  • Extensive knowledge of cGMPs related to equipment and computer system validation/qualification.
  • Expertise in quality investigation techniques
  • Experience with Quality Risk Management (QRM)
  • Previous quality assurance experience

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $32.40/hr.