specialist, quality assurance.
norwood , massachusetts
posted 1 day ago
job detailssummary
$70 - $75 per hour
contract
bachelor degree
category life, physical, and social science occupations
reference49269
job detailsjob summary:As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!location: Norwood, Massachusettsjob type: Contractsalary: $70 - 75 per hourwork hours: 9 to 5education: Bachelorsresponsibilities:The Sr Quality Assurance Specialist is part of the company's Quality Assurance Validation (Quality Engineering) team responsible for ensuring quality oversight of mRNA platform in cGMP Manufacturing, reporting to the Director of Quality Assurance. The main responsibility for this position is to provide quality assurance oversight of CQV Engineering activities, with a focus on reviewing the following types of documents: protocols, reports, SOPs (Standard Operating Procedures), and forms. The individual will work closely with CQV, Facilities/ Engineering, Manufacturing, Quality Control, MS&T, Process Engineering, Tech Transfer, and other teams.
Provides QA oversight of commissioning, qualification, and validation activities.
Responsible for managing the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records in compliance with relevant GxP regulations, guidelines, and company policies.
Ensures timely resolution of documentation, compliance, and quality system issues.
Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, digital, computer systems, validation, methods, and laboratory instruments.
Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method, and computer system validation.
Participates in cross functional project focused meetings for planning and discussing changes to be commissioned, qualified, validated for equipment/facilities/utilities.
Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
Use critical thinking skills to partner with CQV and facility engineers to problem solve.
Executes tasks as defined in internal guiding documents including SOPs and work instructions.
Follows Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Completes training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
Trains service providers and new hires on CQV and QAV processes and procedures.
Reviews and approves work orders related to GMP assets.
Periodically functions as a SME to senior management. Implements an executable plan with direction from leadership.
Proficient understanding of departments beyond immediate stakeholders and involves right parties at the right time with minimal direction.
Able to foresee problems and take individual initiative to proactively prevent them. Demonstrates creativity and innovation in problem solving.
Able to serve as QA technical lead for capital and CQV projects.
Builds strong cross-functional relationships.
Follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
qualifications:
Education: B.S. Degree, preferably in Engineering or Science
Experience: 3-6 Years experience in the biotechnology/biopharmaceutical industry, or other regulated industry. Preferably in Quality Assurance/Validation
Experience in biopharmaceutical & GMP with prior hands-on Validation experience required.
Prior CMMS/EAM knowledge preferred
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice)Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.