Job Number: 20-03171
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!
- Maintains shop floor quality presence; releases raw materials, in-process materials, and finished product; investigates and resolves deviations and complaints; conducts annual product reviews
- Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines
- May assist in preparing for a hosting of regulatory and customer audits
- Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs
- Samples, inspects and releases consumable and raw materials per specifications
- Monitors various stages of processing along with the appropriate paperwork in compliance with specifications
- Drafts and reviews specifications and SOPs. Reviews and approves discrepancy reporting, investigations and CAPAs associated with incoming, in-process and production batch processing
- Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data
- May provide guidance to less experienced staff
- Provides support to manufacturing including quality approval of investigations, participation in change control and area walkthroughs
- Provides QC support including lab inspections, method qualification, method technology transfer, LIMS and Smart Lab support, etc.
- B.S., in Chemistry, Chemical Engineering, Biochemistry or related discipline, or its equivalent is preferred
- 5+ years of relevant experience in a regulated environment with at least 2 years focused on product quality
- Knowledge of biotech bulk and finished product manufacturing, analytical testing is preferred
- Knowledge of US and EU cGMP regulations and guidance
- Strong communication skills and demonstrated ability to influence stakeholders is required
- Knowledge of SAP, LIMS, Delta V, Maximo, Syncade are a plus
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:
Maria Castañeda | LinkedIn
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.