Field Specialist QA Operations

5 days ago

Devens, United States Synectics Inc Full time
Job DescriptionJob Description

Job Description:

  • Responsible for quality activities for the LSCC in accordance with our policies, standards, procedures, and Global cGMP.

  • Perform QA on the floor activities.

  • Ensure manufacturing compliance with applicable procedures and batch records.

  • Perform real time review of manufacturing batch records.

  • Review manufacturing shop floor documentation.

REQUIREMENTS:

  • Relevant college or university degree required.

  • Minimum 4 years relevant work experience, with experience in a Quality Assurance role.

  • Equivalent combination of education and experience might be acceptable.

  • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

  • Understands continuous improvement and improves efficiency and productivity within the group or project.

  • Builds relationships internally within and with cross functional teams.

  • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.

  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.

  • Able to recognize conflict and notify management with proposed recommendations for resolution.

  • Must possess an independent mindset. Work is self-directed.

  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

  • Confident in making decisions for non-routine issues.

  • Develops and revises procedures.

  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

  • Able to prepare written communications and communicate problems to management with clarity and accuracy.

  • Able to effectively multi-task.

  • Knowledge of US and global cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

  • Must be skilled in planning and organizing, decision-making, and building relationships.

  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

  • Able to effectively multi-task.

  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.

  • Must be skilled in planning and organizing, decision-making, and building relationships.

  • Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.

  • Work Schedule is a 2 week rotation as detailed here: * 5am to 5:30pm, 2 on (Tue, Wed) * 2 off (Thurs, Fri) * 3 on (Sat, Sun Mon) * 2 off (Tues, Wed) * 2 on (Thurs, Fri) * 3 off (Sat, Sun, Mon) Holidays included as the needs of the business warrant.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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