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On Board Companies is Hiring a QA Lead Technical Operations Near Devens, MA
On-Board Scientific is hiring a QA Lead – Technical Operations in Devens, MA For immediate consideration please send your resume to Subject Line: Position, Title, and State you are Located About UsOn-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k. Position DetailsJob title: QA Lead – Technical Operations Position Type: Full Time / 6-month contract Job location: Devens, MA 100% onsite Shift: M-F 8:30AM-5PM Responsibilities
Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and
approval of Investigations and Corrective Actions.
Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
Reviews and approves Quality, Quality Control, Validation and Automation related documents
Review and approves Standard Operating Procedures (SOPs).
Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and
summary reports.
Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet
external regulatory and internal WWQC guidelines and requirements. Qualifications
Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk
assessments and Validation.
Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working
environment
Able to interpret complicated data and make sound decisions, Independently
Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering,
biochemistry, or related discipline, or its equivalent is preferred.
Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product
Quality. Preferred Active Member Of ASQ Or ISPE.
Prior experience of QC equipment Qualification and some project management experience
Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is
highly desirable.
Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic
or paper based batch records desirable.
Excellent Technical writing and oral communication skills are required.
Background in problem solving
Knowledge of Data integrity principles
Proven attention to details
Comfortable working in an FDA regulated environment.
Selected candidates will be required to enter a structured training program and successfully complete all modules including Biologics orientation training, general knowledge training and job function training and successfully complete training modulenevaluations at 1, 3, 6 and 12 month milestones. Apply Today! On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.” On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics. (phone number removed) INDOJ