Job title: Quality Assurance Associate II Duration: 12 Months Location: Framingham, MA (Hybrid Role)
Work Schedule
8:00 am - 4:30 pm EST; Mon-Fri
HM Notes:
3-6 years of experience, but open to someone with less experience.
A minimum of 2 years in the Pharmaceutical Industry with at least 1 in a quality environment.
Open to candidates willing to relocate at their own expenseo
M.S./MBA plus 2 years’ experience in a pharmaceutical or GMP environment with at least 1 year in a Quality related field.
Minimum B.S. plus 4 years’ experience in a pharmaceutical or GMP environment with at least 2 years in a Quality related field
Degree preferably in Science field- possibility for OT, but not required
Top 3 must-haves Attention to detail is critical, communication, organizational skills Top 3 nice to have PM, knowledge of EU and FDA guidances, experience in a Quality role, experience in a GMP environment, aseptic processing experience
Job Highlights: • Support timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectations prior to release and/or approval. • Maintain organization of project deliverables for external partner project using applicable tools. • Identify and communicate quality risks in a pro-active and collaborative manner maintaining the business interests of company's and consideration of suitable outcome for the projects. • Participate in and support batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies. • Develop trusting team partnerships to ensure highly collaborative project outcomes. • Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).
Requirements Years Experience: 3-6 years;
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.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $42.00/hr.
