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QA Raw Materials Specifications Associate- 1st shift 8-5pm

Company: Planet Pharma
Location: Severn
Posted on: May 31, 2021

Job Description:

The QA, Raw Materials Team is responsible for ensuring the quality of incoming materials and components meet quality expectations needed to assure patient safety. This begins with assuring the material requirements are formalized as specifications for receiving materials intended for GMP manufacturing.The QA RM Specification Associate is responsible for the following: Create raw material specifications according to template requirements and information provided by technical groups.Route Specifications for review and approval through workflow in Master control. Review edits and revise Raw Material specifications as indicated.Edit raw materials specifications as needed for client requests or supplier change notificationsCreate change controls and represent QA-RM team at Change Control review board as neededEngage with technical teams and Supply Chain as necessary to proactively collect documentation for pending specifications.Adjust the materials specification templates as needed to assure compliance with regulations and client expectations. SKILLS & TECHNICAL EXPERTISE: Experience with Good Manufacturing Practices (GMPs) a plusExperience using MasterControl and ability to create workflows and reports from these systemsExpert in formatting in Microsoft Word and use of edit tools.Good communication skills and ability to work in a group setting where priorities may be shifted weeklyAbility to work in a cross functional team and escalate concerns related to priorities and patient first concepts SUPERVISION: Work closely with Supervisor to schedule work expectations and priorities on a daily or weekly basis MEASUREMENT OF PERFORMANCE: Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to the teamTimeliness and accuracy in completion of projects and paperwork (quantity and quality of work)Identification of problem areas affecting workload expectations (knowledge/problem solving)Offers suggestions for correcting problems and creating more lean processesDemonstrated understanding and adherence to Clinet policies, safety procedures and the cGMPsAbility to succeed in a team-oriented environment under very dynamic conditions EDUCATION/PREVIOUS EXPERIENCE: B.S. in a Life Sciences disciplineHands on experience with Master Control creating documents for a GMP environment, a plus.Experience with Good Manufacturing Practices (GMPs) and 21 CFR part 11, a plus

Keywords: Planet Pharma, Severn , QA Raw Materials Specifications Associate- 1st shift 8-5pm, Other , Severn, Maryland

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