QA Specialist (Pharma/Biotech/Medical Device)

List required and preferred qualifications (up to 10). Include education, skills and experience. Bachelor’s degree preferably in Engineering or Science Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process Knowledge of GMP regulations and standards affecting pharmaceutical products Comprehensive knowledge and application of business and quality concepts Strong analytical skills and attention to detail Change plan, Exception Reports, SAP and LRMS experience is highly preferred Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization What are the top 3-5 skills, experience or education required for this position? Bachelor’s degree preferably in Engineering or Science & Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process Strong analytical skills and attention to detail and, strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization Knowledge of GMP regulations and standards affecting pharmaceutical products Comprehensive knowledge and application of business and quality concepts Change plan, Exception Reports, SAP and LRMS experience is highly preferred 6Fully Bilingual English & Spanish Candidate may work independently and have experience in Quality systems What is a nice to have (but not required) skill, experience, education, or certification? n/a In what type of environment would this individual be working (i.e.: Team; Individual; type of office, etc.) ? Candidate may work individually and with area team In cubicle Daily Work Schedule Expectations Monday to Friday 8-5PM Is overtime offered or required? Candidate must be available based in business needs Does this position offer the ability to work remotely on a regular basis or is it required to be onsite? Candidate may work remotely some days a week Based in business needs If remote opportunity exists what are the options (i.e., 1 day remote, 4 days on-site)? Candidate may work remotely some days a week Based in business needs Is Travel expected? If so, will it primarily be domestic or international? Not expected. Job Type: Contract Pay: $40.00 - $42.00 per hour Expected hours: 40 per week Benefits: Health insurance Education: Bachelor's (Preferred) Experience: Quality Assurance: 6 years (Preferred) Pharma/Medical Device/Biotech Industry: 6 years (Preferred) SAP OR LRMS: 6 years (Preferred) Change Control: 6 years (Preferred) Ability to Commute: Barceloneta, PR 00617 (Preferred) Work Location: In person