Labeling Specialist Rahway, NJ 07065 12 months • Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
Typical day: • Very intensive label-oriented job • Need someone to hit the ground running. • Lot of label review and submission. • Quality check for label content and formatting as per FDA guidelines. • Support the team with the review, revising labeling. • Attention to details. • Will review labels on packaging, container, carton boxes. • Will prepare the label content following SOP’s and FDA regulations.
Qualifications: Education: Associate/Bachelor of Life Science/Master's degree.
Required Experience and Skills: • With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience • With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience • With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience • Require someone with scientific background or familiarity with medical terminology. • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint. • Excellent English oral and written communication skills and presentation skills. • Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology
Personality: • Attention to details • Team Player • Can work independently • Excellent communication and written skills
Responsibilities: • Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). • Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines. • Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations. • Maintain databases and team sites by ensuring updated and accurate information is uploaded.
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: $24.00/hr.
