Manufacturing support specialist

job summary:
Are you a detail-oriented Life Sciences or Engineering professional looking to expand your expertise in biopharmaceutical manufacturing support? This high-impact, 6-month contract role in Westborough, MA ($45-$55/hr) offers an exceptional opportunity to dive deep into a GMP environment by leading medium-to-high level deviation investigations, driving CAPA implementations, and supporting vital technology transfers and equipment qualifications. If you have a Bachelor's degree, 1+ years of experience in a Quality or Manufacturing setting, and a strong grasp of QMS documentation and continuous improvement, this role provides the perfect platform to sharpen your technical skills and accelerate your career in commercial readiness and process optimization.

location: Westborough, Massachusetts
job type: Contract
salary: $45 - 55 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:

• Provide input on/carry out investigations on medium and high-level deviations.
• Support change control activities related to manufacturing - process changes, new product introduction, new equipment and technology introduction, etc.
• Support site and corporate objectives to deliver programs as per established timelines.
• Coordinate and assist with technology transfer activities.
• Support equipment qualification/validation activities in the capacity requested by Manufacturing.
• Assist with Data Integrity (DI) assessments of manufacturing equipment.
• Develop and implement Corrective and Preventive Actions (CAPAs).
• Implement continuous improvement projects.
• Perform risk assessment activities including raw material risk assessments.
• Developing/drafting and revising documentation including study protocols/reports, batch records and standard operating procedures (SOPs).
• Support commercial readiness activities.

qualifications:
Required:

• Bachelor's degree in Quality, Manufacturing, Biology, Engineering, Life Sciences or a discipline justifiably related to pharmaceuticals/biopharmaceuticals.
• More than 1 year of experience in a Quality or Manufacturing environment.
• Knowledge of QMS documentation, risk management and risk documentation.
• Basic understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Proficiency using Microsoft Word, Excel, and PowerPoint.
• Detail-oriented with good organizational skills.
• Strong oral, written and interpersonal skills.
• Willingness to collaborate cross-functionally and with external vendors, original equipment manufacturers, etc.
• Ability to manage changing priorities and maintain timelines for multiple projects in a fast-paced setting.
• Ability to work effectively independently and as part of a team.

Preferred :

• Relevant experience within Pharmaceutical or medical device companies.
• Basic project management skills.
• Experience with continuous improvement projects.

#LI-KH1

skills: SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Management Systems (QMS)


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 View email address on click.appcast.io.


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.