We are seeking a highly motivated and detail-oriented individual to join our team as a Pharmaceutical Operations & Quality Specialist. This multifaceted role will contribute to critical functions across Manufacturing, Quality Assurance (QA), and Quality Control (QC), ensuring that our products are produced efficiently, consistently, and in full compliance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical processes, a commitment to quality, and the ability to work collaboratively in a dynamic environment.
location: West Greenwich, Rhode Island
job type: Contract
salary: $25 - 35 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Manufacturing Operations
- Execute manufacturing processes according to established Standard Operating Procedures (SOPs), batch records, and production schedules.
- Operate and monitor manufacturing equipment, ensuring proper functionality and adherence to safety protocols.
- Perform in-process checks and sampling as required by batch records.
- Maintain accurate and detailed documentation of all manufacturing activities, including batch records, logbooks, and equipment usage logs.
- Participate in equipment cleaning, setup, and minor troubleshooting.
- Identify and report any deviations, non-conformances, or issues during the manufacturing process.
- Contribute to process improvement initiatives to enhance efficiency and product quality.
- Review and approve manufacturing batch records, laboratory data, and other quality-related documentation to ensure accuracy, completeness, and compliance with internal procedures and regulatory guidelines (e.g., GMP, ICH, FDA).
- Participate in the investigation of deviations, non-conformances, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results, ensuring thorough root cause analysis and effective resolution.
- Assist in the development, revision, and implementation of Quality Management System (QMS) documents, including SOPs, policies, and specifications.
- Conduct internal audits and support external regulatory inspections (e.g., FDA, EMA) and customer audits.
- Ensure timely release or rejection of raw materials, in-process materials, and finished products based on quality specifications.
- Provide quality oversight and guidance to manufacturing and other departments.
- Perform routine analytical testing of raw materials, in-process samples, finished products, and stability samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, dissolution, titrations, microbiology assays).
- Interpret and analyze test results, ensuring accuracy and adherence to specifications.
- Maintain and calibrate laboratory equipment, ensuring proper functioning and compliance with calibration schedules.
- Document all laboratory activities meticulously in lab notebooks and electronic systems.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, documenting findings and participating in root cause analysis.
- Prepare and review analytical reports, certificates of analysis (CoAs), and other QC documentation.
- Ensure the laboratory operates in compliance with GMP, GLP (Good Laboratory Practices), and safety regulations.
qualifications:
Required:
- Associate's or Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline
- Minimum of 1+ years of experience in the pharmaceutical, biotechnology, or a highly regulated manufacturing industry, with exposure to Manufacturing, Quality Assurance, and/or Quality Control functions
- Proven understanding of GMP, GLP, ICH guidelines, and relevant regulatory requirements (e.g., FDA 21 CFR Parts 210/211)
- Ability to be involved with exposure to chemicals, solvents, and biological materials, requiring adherence to safety protocols and use of personal protective equipment (PPE).
- Ability to work off-shift or weekend work as required based on production schedules and business needs
skills: Quality control, HPLC, SOP, Quality Assurance, CAPA, Analytical Chemistry, Chemistry, GLP (Good Laboratory Practice), Microbiology, ICH Regulations, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.
