REPORTS TO: Quality Control Raw Materials Supervisor
REPORTING RELATIONSHIPS: Reports to supervisor or Manager, no direct reports
Responsible for conducting analyses of raw materials, manufacturing environment, in-process & finished formulations according to SOPs. Compiles data for documentation of test procedures and prepares reports. Provides QC input and support throughout the client (e.g. projects, product transfers and inspections). Ensures all testing processes, monitoring, and departmental documentation meet the client and cGMP regulatory standards. Contributes to the development of new concepts, techniques, and standards. Has an understanding and application of principles, concepts, practices, and standards. Involved with set up of raw material receipt, handling and testing requirements. This position will work with corporate quality assurance to ensure all raw materials and finished products conform to company and customer specifications.
* Document work clearly, accurately, and in accordance with cGMP.
* Responsible for effectively and professionally working with customers when required.
* Has good understanding and application of principles, concepts, practices, and standards.
* Recommends and guides implementation of functional strategies across group.
* Flexible to meet changing demands to support manufacturing activities.
* Assist in the resolution of customer complaints.
* Completes tasks where judgment is required in resolving problems & making recommendations.
* Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.
EDUCATION AND QUALIFICATIONS:
* BS in Biological Science or related technical field.
* At least 3 years of related experience or equivalent combination of education & experience.
* Extensive exposure to cGMP environment.
* Knowledge of organizational methods and the ability to manage multiple tasks or projects simultaneously.
* Knowledge and ability to implement, track and ensure adherence to all safety training requirements related to the Quality Controls team.
ESSENTIAL JOB FUNCTIONS:
Support multiple groups within QC and works closely with appropriate Manufacturing personnel to ensure timely resolution of issues. Engage, develop, and follow the Quality Controls team with efficient direction and training of quality processes and procedures, while working towards goals and meeting performance metrics, to continuously improve standards and foster teamwork. Work on Quality Procedures, Raw material specifications, and Biosafety Programs. Train on applicable quality systems and certification programs (cGMPs, SOPs, etc.) Ability to perform raw material sampling using aseptic and other techniques. Releasing materials from Quarantine to the Warehouse
Maintaining sampling supply inventory. Maintaining cleaning and up keep of all sampling equipment and sampling room. Act as technical representative for all in-house audits by certified bodies, customers, or regulatory authorities. Ability to participate in internal audits for compliance. Quality Control programs and functions, including laboratory testing and quality systems. Ensures company's overall quality policies are being followed. Inspect / sample / and/or test raw materials, or other tests as required in a timely manner. Work with procurement and manufacturing sciences per raw materials to ensure vendor compliance with specifications. Work on projects independently with limited supervision.
Frequent use & general knowledge of industry practices, techniques and standards. Review and approval of material release disposition record packets, and investigation of any process deviations that have occurred. Manage priorities and work schedulesaccording to companies' needs and demands. Responsible for data entry and verification of laboratory analyses in a timely manner. Coordinate sampling and release of product after tests are completed for conformance to specifications. Coordination of the disposition of off specification product. Maintain customer product specifications and assist in evaluation of new customer specifications. Conduct calibration and maintenance of laboratory equipment. Purchase and maintain laboratory equipment and supplies. Assist in completion of Change Control activities for the facility. Assist in the resolution of customer complaints. Provide support to PD and technical support as needed. General application of concepts and principles. Assist with developing solutions to variety of problems of moderate scope & complexity. Refers to policies & practices for guidance.
Participates in revisions, providing input, as necessary. Authoring/revising SOPs, method development, and validation protocols/reports. Perform assay method development and validation/equip validation under direct supervision.
Train on basic to complex assays and lab procedures as required. Complete projects assigned by determined deadlines. Able to multi-task efficiently to ensure timely project completion. Assist management in evaluating and implementing new techniques and technologies with guidance.
Participate in laboratory support functions (e.g., cleaning, logbook review, material stocking).Mentor junior staff. Improve and develop systems to meet current GMP standards. Document work clearly, accurately, and in accordance with cGMP. Assist with investigations for deviations.
Miscellaneous tasks as necessary.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.