Job Number: 21-08703
Job Number: 21-08703
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate for our client in Devens, MA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Executes quality assurance activities in the incoming material process such as inspection/review of consumables and raw materials.
- Performs quality review for area documents including GMP forms, logbooks and batch records.
- Provides floor support of warehouse and cryogenics functional areas, including walkthroughs and inspection readiness activities, on a day to day basis.
- Assist with the lifecycle management of material qualifications, including reduced testing and direct dispense.
- Assists quality assessment of Supplier Change Notifications for impact to site.
- Assists in discrepancy reporting, deviations and CAPAs associated with nonconforming/defect material.
- Assists/Owns CAPA execution and drives actions through to completion.
- Work is largely performed in a modern office and manufacturing/warehouse facility where one must be aware of the presence of workplace hazards including pressurized liquids gases, steam and hazardous chemicals.
- Use of Personal Protective Equipment (PPE) will be required in some portions of the facility.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Resolves simple problems in addition to identifying and assessing risks.
- Requires increased supervision where work is reviewed and measured based on meeting established timelines, objectives and schedules.
- Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
- A minimum of 2 year with directly relevant experience in a regulated environment is required.
- Basic knowledge of regulated activities such as Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Demonstrate proficiency in common computer tools such as word processing, spreadsheet and web based applications.
- Past experience where one was required to work in a team based environment with a diverse group of people.
- Previous work experience where attention to detail and personal accountability were critical to success.
- Strong communication skills and the ability to follow written and verbal instructions.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.