Job Number: 20974515
STERILITY ASSURANCE SPECIALIST
Hybrid role - candidate must be flexible to work onsite 2-3 days per week or more, as needed.
- The Specialist, Quality Systems and Compliance, Sterility Assurance (SA) is accountable for maintaining regulatory compliance for the Environmental Monitoring (EM) program and Sterility Assurance programs at the Client's Durham, NC Vaccine manufacturing facility.
- The incumbent will execute trend reports and collate data for performance communication to Operational areas.
- The role will require working closely with Quality, Technical, Operations, and IT organizations at the local level.
- Works in an empowered, self-directed culture with a great deal of independent decision making in the planning, coordination, and execution of multiple independent projects.
- Executes periodic trend reports in GLIMS.
- Manages the gowning program and aseptic room access.
- Evaluates data from GLIMS and AOP to determine overall performance on the environment monitoring (EM) systems (personnel and facility).
- Drafts/updates procedures impacting the EM processes.
- Provides support to Quality during regulatory inspections and audits.
- Maintains an active dialog and communication between affected departments and leadership to ensure project progress and milestone success.
- Delivers aseptic training to operations and Quality.
- Analyzes and solves problems using standard problem-solving processes.
- Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
- Business Expertise:
- Understands the fundamental business drivers for the company; uses this knowledge in own work.
- Understands and applies regulatory / compliance requirements relative to their role and the role of their team.
- Functional Expertise:
- The Specialist, Quality Systems and Compliance, will be responsible for providing support for regulatory and cGMP compliance programs and initiatives to include the following:
- Support robust site-wide systems to manage EM/Classified Utilities and SA-related activities.
- Manages review and implementation of EM system enhancements as-needed basis.
- Reviews and revises SOPs as appropriate.
- Supports operational excellence initiatives targeted to increase the speed, flexibility, and efficiency of processes as appropriate.
- Performs special quality projects / investigations as requested by Senior Quality Management.
- Other duties as requested by Quality management.
- Influence / Decision Making / Problem Solving:
- This position has an influence on the continuous improvement of existing and new products at the Durham site through support of efficient, effective EM systems that lead to the expansion of the Durham product portfolio.
- The individual in this role is required to make real time decisions in a time constrained environment.
- This role requires interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Compliance responsibilities.
- Associate Degree in science related field.
- Pharmaceutical experience in biological sciences or related fields.
- A minimum of 2 years in a quality function that supports compliance, release and/or environmental monitoring supporting a GMP manufacturing facility/ utilities.
- Previous environmental monitoring experience in a clean room environment.
- The candidate must possess highly developed communication, leadership, and teamwork skills.
- Proficiency in Microsoft applications (Excel, Word, PowerPoint, Power Apps)
- Ability to teach/develop new employees.
- Experience in GMP biologics manufacturing facilities.
- Knowledge of CFR, EudraLex and other regulatory guidance specific to the pharmaceutical industry.
- Strong analytical and problem-solving skills.
- Effective communication skills (both written and oral).
- Ability to multitask and manage/prioritize multiple projects and deadlines.
- Strong customer service focus.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Supriya: supriya@AlphaConsulting.Com
ALPHA'S REQUIREMENT #22-02034
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE