The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic, results-oriented, and experienced Quality Assurance Specialist to join our organization as a Remote Worker. The candidate will be responsible for supporting the global Manufacturing Execution System (MES) projects and initiatives to ensure compliance, quality assurance, and operational excellence in a GMP-regulated environment. This is an excellent opportunity for a highly experienced and talented individual to contribute to Company's mission of serving patients.
Schedule/Shift: Full time, REMOTE position. Preference is given to candidates who can work standard business hours in the Eastern Time Zone (EST) to support key project stakeholders.
location: Telecommute
job type: Contract
salary: $35.00 - 39.84 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Ensure quality oversight and compliance for MES and PT project activities.
- Support validation and qualification efforts for computerized systems in alignment with GMP requirements.
- Review and approve documentation related to MES workflows, change controls, and deviations.
- Collaborate with cross-functional teams to ensure quality standards are met during system implementation.
- Participate in risk assessments and support mitigation strategies for quality-related issues.
- Ensure that quality processes and procedures are updated and aligned with project deliverables.
- Provide training and guidance on quality practices and regulatory compliance.
- Support audits and inspections by providing documentation and subject matter expertise.
- Monitor and report on quality metrics and continuous improvement initiatives.
- Ensure alignment with global quality standards and local regulatory requirements.
qualifications:
- Bachelor's degree (BS) in Life Sciences, Engineering, or related field.
- 4-5 years of experience in Quality Assurance or related roles within a GMP / GxP regulated pharmaceutical or biotech environment.
- Minimum 1-2 years of direct, hands-on experience working with Körber's PAS-X Manufacturing Execution System (MES), including design, deployment, and support.
- Experience integrating PAS-X MES with Level 2 (automation / control systems) and Level 4 (enterprise systems like SAP).
- Proven experience in quality assurance within a GMP-regulated manufacturing environment.
- Experience supporting MES and process transformation initiatives.
- Strong understanding of validation principles and regulatory compliance.
- Excellent documentation and communication skills.
- Ability to work collaboratively in cross-functional teams.
- Detail-oriented with strong analytical and problem-solving skills.
- Comfortable working independently in a remote setting; strong preference for candidates located in the Eastern Time Zone (EST).
skills: 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
