Quality Specialist - I Assistant

Qualifications Education: Bachelors degree/Masters degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience. Required Experience and Skills: Minimum 1 year of relevant postdegree work experience in a laboratory manufacturing or quality position. Evidence of good oral and written communication skills i.e. effective presentation of concepts and ideas as well as interpersonal and conflict resolution skills. Attention to detail flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. Preferred Experience and Skills: Familiarity with vaccine and/or pharmaceutical processing. Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus. Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial. Familiarity with computer systems (SAP LIMS electronic batch records) is a plus. Personality: Self sufficient Adaptable Collaborative Team Player *Note*:Hybrid role (12 days/week remote option only when contractor is fully trained). Flexible schedule. Not interested in candidates with short term assignments on their resumes. Looking for GMP/PHARMA/BIOPHARMA profiles with batch record documentation experience. *Not looking sample testing/chemist/biologist/microbiologist profiles*. Possibility of extension. Key skills: Quality operations background. Batch record review experience Documentation experience SAP/LIMS/ electronic batch records(EBR)
Responsibilities MMD is looking for a contractor in their dynamic quality department. This candidate provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. With guidance from the IPT Quality Leadership team the employee ensures product / process quality and performs activities to facilitate the release of product to the marketplace. The candidate performs 100% process document review for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time. Specific responsibilities include but are not limited to the following: Performs 100% audit of process documents to ensure completeness and accuracy for assigned End to End (E2E). Maintains any tracking databases and logs associated with this review. Coordinates with Production to discuss resolve and eliminate documentation observations. Actively participates in the Tier process and uses this forum to escalate concerns and best practices. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans Prioritizes review of process documents in order to maximize cycletime efficiency. Performs SAP transactions required to document Batch Record review.
Comments/Special InstructionsSr. SCP Vidushi Sharma. Key skills: Batch record review experience Documentation experience SAP/LIMS/ electronic batch records(EBR)
System Location: Manufacturing (Z007) Required
Job Title: XX(document).ready(function () var XXlnkJobTitle XX(#ctl00CPHucClientJobTitleDoclnkJobTitle); XXlnkJobTitle.attr(href #); XXlnkJobTitle.on(click function (event) event.preventDefault(); var url XX(this).attr(url); var filepath XX(this).attr(filepath); var doccount XX(this).attr(doccount); if (doccount > 1) EP.openDialog(url); else window.open(url url : filepath); ); ); Quality Specialist I (Assistant)
CWR Type: W2 Required