Massachusetts Healthcare Jobs

Validation Specialist III

Location:Boston, MA, United States

Job Type:Contract

Job Category:Quality

Job Industry:Pharmaceuticals and Medical Products

Salary:The pay we're offering is $40 - $50 per hour

Description

We're looking for aValidation Specialist III, working inPharmaceuticals and Medical Productsindustry inBoston, Massachusetts, 02134, United States.

Job description:

• Manages and implements Laboratory Equipment Qualification system. It's goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets the intended use.

• Qualifies computerized instrument associated software used for analytical and microbiological testing at the facility.

• Executes and coordinates activities to qualify software, writing protocols, reports and procedures, coordinating the purchase, commissioning and introduction to the QC laboratory.

• Establishes and maintains Equipment History Files (EHF).

• Coordinates all services provided by vendors, ensuring vendors meet all site requirements.

• Schedules/plans/executes validation activities.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

Education and Experience:

• Bachelors Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of Industry relevant experience, OR

• Masters Degree in Chemistry, Life Sciences, or Engineering discipline and 3 years of Industry relevant experience

Requirements:

• Demonstrated scientific technical writing ability

• Knowledge of USP 1058 and GAMP methodology

• Knowledge of 21CFR Parts 11, 210, 211, 600 and 610 and Annex 11

• Previous hands on experience performing software validation compliant with 21CFR Part 11 and Annex 11

• Proficient in Outlook, Microsoft Word, and analytical instrumentatin software, e.g. SoftMax Pro

• Ability to gown and enter laboratory May require off shift work to support activities

What Do You Think?

Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?