Massachusetts Green Jobs

specialist, quality assurance on the floor (qa otf).

• norwood , massachusetts

• posted june 6, 2024

job details

summary

• $40 - $50.97 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48269

job details

job 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, Massachusetts

job type: Contract

salary: $40.00 - 50.97 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

The company is seeking a Specialist to support Quality on The Floor (OTF) oversight of manufacturing activities and Facilities.. This position will be based in our cGMP Manufacturing site in Norwood, MA and will directly support the growing Personalized Medicine Program at the Norwood, MA site. The main responsibility for this position is to provide quality oversight of manufacturing and Facilities, with a focus on quality on the floor overseeing manufacturing operations including real time review of electronic and paper batch records, minor deviations, alarms, CAPAs, training, and other technical documents. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, and Facility teams.

• Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs etc.

• Support quality decisions that may impact operations, ensuring appropriate escalation.

• Identify risks and communicate gaps for quality and GMP process/systems.

• Reviews and approves facility alarms, facility work order requests, and return-to-service documentation.

• Supports, reviews and approves Deviations and change controls

• Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.

• Collaborate with Manufacturing to resolve equipment and process issues

• Support internal audits.

• Practice safe work habits and adhere to the company's safety procedures and guidelines.

• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

• Follow 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.

• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

qualifications:

• Education: Bachelor's degree.

• Experience: BS with 3+ years of experience, or a Master's level degree with at least 1 year experience in the pharmaceutical/biotech industry.

• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

skills: SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice), Manufacturing Operations

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).

Applications accepted on ongoing basis until filled.