Lead Quality Control Technician at Shire Human Genetic Therapies, Inc.

Posted in General Business 13 days ago.

Type: Full-Time
Location: Lexington, Massachusetts





Job Description:

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Job Description

Primary Duties

Primary duty of this position is operational support for the QC GMP functions, both for cross-functional teams as well as for core laboratory operations support.

Discretion/Latitude:

Minimal supervision. Work may be done without established procedures.

Impact:

Errors are very difficult to detect and would normally require significant expenditures to resolve.

Specific QC Focus Areas:

Sample Control:

Area focuses on sample receipt/login/inspection, sample and retain management, QC records archival and control, coordination of materials for external shipping, aliquoting of samples, stability study initiation and time point pulls, and supporting laboratory operations, including buffer and reagent preparation.

Responsibilities: Job Function and Description

30-50%

Operational support activities such as reagent and buffer preparation, chamber maintenance including sanitization, sample management, records management, QC area housekeeping activities and lab support duties, data review, shipments to CMOs/CTLs, and stability pulls

25-30%

Sample handling activities including product complaint evaluations, reference standard and assay control aliquoting and inventory maintenance, reserve and retention sample annual inspections

20-35%

Coordination with other departments to facilitate support activities and/or leading on non- routine projects within the department, involvement on cross-functional projects

Education and Experience Requirements

Essential: 

  • Requires a high school diploma and a minimum of 6+ years related experience (Higher degrees may reduce the minimum years' experience required)

Desired:


  • Excellent communication, interpersonal and organizational skills.

  • Ability to work well with modest oversight and in a team environment.

  • Ability to prioritize work and multitask.

  • Conducts work in compliance with cGMPs, safety and regulatory requirements

Key Skills, Abilities, and Competencies

Knowledge:

  • Full knowledge of the job. Substantial acquaintance with and understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.

Key Skills:

MS Office, LIMS, TrackWise, EDMS

Complexity and Problem Solving

Works on assignments that are complex in nature where judgment is required in resolving problems and making routine recommendations. Applies job skills and company's policies and procedures to complete a wide range of difficult tasks.

Internal and External Contacts

Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation from individual.

Other Job Requirements

Travel between MA Bio Ops sites may be required.

The following physical abilities are required in order to fulfill the job duties:


  • Ability to lift, pull, or push equipment requiring 50 lbs of force

  • Repetitive bending and reaching to setup and break-down equipment

  • Ability to climb ladders and work platforms

  • Ability to work around chemicals

  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases

  • Ability to walk and stand for periods of time

  • Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

If individual is to be trained to execute certain test method where visual evaluation is required, the individual maybe required to take a medical examination for vision and color blindness (as required by the specific test in question).

This job posting excludes Co Applicants

#GMSGQ

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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