Experience Inc. Jobs

quality assurance specialist - gmp.

• burlington , massachusetts

• posted april 4, 2024

job details

summary

• $45 - $50 per hour

• temp to perm

• bachelor degree

• category production occupations

• referenceAB_4506772

job details

Our client, a large company in the biopharmaceutical industry, is seeking a Specialist/Senior 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 Burlington, MA and will directly support the growing Personalized Medicine Program. The main responsibility for this position is to provide quality oversight of manufacturing. strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality, and Facility teams. Required Background:

• 4+ years of experience in the pharmaceutical/biotech industry

• Demonstrated aptitude or ability to learn to gain a strong understanding of GMP/GLP/GCP regulations

salary: $45 - $50 per hour

shift: First

work hours: 6 AM - 6 PM

education: Bachelors

Responsibilities

• 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.

• Support, reviews and approves Deviations and CAPAs

• 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 Moderna'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.

The essential functions of this role include:

• working in a smoke free environment

Skills

• QA/QC

• QAQC

• Quality Assurance

• Quality Control

• quality

• visual inspection

• QC testing

• quality testing

• SOP

• SOPs

• cGMP

• GMP

• audit process

• LIMS

• document management

• change control

• CAPA

• CAPAs

• Pharmaceutical

• chemistry

• biology

• life sciences

Qualifications

• Years of experience: 4 years

• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

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.

get in touch

we are here to help you with your questions.

SD

samantha dougherty

• sam.dougherty@randstadusa.com