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PDS Tech Inc Material Handler, Quality Control in Somerville, Massachusetts

PDS Tech is seeking candidates for a Material Handler for Quality Control position in Somerville, MA

JOB SUMMARY/OBJECTIVE:

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 Brammer Bio (e.g. projects, product transfers and inspections). Ensures all testing processes, monitoring, and departmental documentation meet Brammer Bio 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

1)

30%

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

2)

25%

Maintaining sampling supply inventory. Maintaining cleaning and up keep of all sampling equipment and sampling room. Act as a 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 the 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.

3)

20%

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 schedules according 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 the 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.

4)

10%

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.

5)

5%

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.

6)

5%

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.

7)

5%

Miscellaneous tasks as necessary.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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