Acton, Massachusetts, United States
Job type: fulltime
Job industry: Other
ACS Solutions has an immediate need for a Quality Assurance with experience in the pharmaceutical Industry. This is a 06 months contract opportunity is located in Devens,MA. Our client is a leading PHARMACETUICAL company.
Please review the job description below:
Top Skills: QUALITY ASSURANCE,BATCH RECORDS,CAPA,TRACKWISE,LIMS
Maintains shop floor quality presence; releases , 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.
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.
Key Requirements and Technology Experience:
* 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
Knowledge of integrated electronic systems, including electronic batch record review is highly desirable.
If it creates an interest for you, please email me the latest copy of your resume.
Thanks and regards,
ABOUT ACS Solutions. - ACS Solutions is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
#No. 6 Largest IT staffing Firm in the U.S. (2019 SIA)
#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
# No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA)
#Inavero's Best of Staffing® Client Diamond Award (2018).
#National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC
#Inavero's Best of Staffing®Client Diamond Award Winner(2017)