[ref. n08924724] Randstad - USA-Quality Control Technician I (Manufacturing/Quality) 1st Shift
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location: Framingham, Massachusettsjob type: Contract
salary: $28.00 - 30.57 per hour
work hours: 9 to 5
education: Associate
responsibilities:This position is responsible for activities related to management of Product Technical Complaints for medical devices, pharmaceutical products, biologics and combination products. Knowledge of regulatory requirements, GMP, GDP, quality & compliance and complaint handling is preferred.
Job Responsibilities- Responsible for E2E operations conducted in PQC Sample Room
- On site support 5 days/week, ability to work wearing PPE
- Responsible for handling used complaint samples
- Process returned complaint samples as per PQC Sample Room Manual
- Identifies and handles lot discrepancies correctly with returned complaint samples.
- Updates the complaint records in the systems.
- Prepares products for shipments to the manufacturing sites
- Prepare shipping labels using FedEx equipment.
- Assemble shipping containers to the sites
- Deliver assembled mailers to main mail room or arrange for daily pick up
- Responsible for resolving all discrepancies directly with the reporters
- Create new complaints in both Meteor and Qualipso
- Identify complaints for FAR/BPDR (Field Alert and Biological Product Deviation Report) reporting as necessary
- Use various Excel reports for daily operations.
- Act as a SME on PQC Sample Room operations and provide support during audits and inspections
- Act as a trainer for new associates
- Manage PQC Sample Room Manual
- Complete all required trainings (i.e. DOT, IATA, blood borne pathogens)
- Manage all supplies and maintain inventory required for daily operation of a PQC Sample Room
- Order supplies and work directly with the vendors for customized PO
- Responsible for maintaining all equipment and tools in PQC Sample Room
- Proficient with use of all databases within the department (ie. Meteor, Qualipso, Microsoft Office).
- Understands the importance of processing GxP data according to GDP foundations
- Knowledge of all company products marketed in the US
- Understands PQC process flow
- Understands the FDA complaints regulations for the drug, combinations products and medical devices.
- Maintains PQC reports as needed
- Understands export shipping requirements for shipment of waste pharmaceuticals to overseas manufacturing sites.
- Prepare international shipping manifests, commercial invoices and customs forms
- Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial, Operations, Legal, and Risk Management.
- Performs other duties as assigned.
- Ability to lift/move 20lb and work standing 50%
- Maintains use of Universal Precautions while working
qualifications:
- Associate degree in science or related field of study
- 2 years of pharmaceutical industry experience. Will consider an advanced degree in lieu of years of experience.
- Strong Verbal and Written Communication skills.
- Excellent interpersonal skills.
- Strong organizational and prioritization skills.
- Ability to multi-task in a fast-paced environment
- Adept at attention to detail
- Strong understanding of Good Documentation Practices and GxP
- Familiarity with medical terminology.
- Work effectively and cooperatively with others; establish and maintain good working relationships.
- Computer literate-proficient in use of Microsoft Office. Must be able to understand and utilize complaint database software and reporting tools.
- Ability to lift/move 20lb and work standing 50% while wearing personal protective equipm
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GLP (Good Laboratory Practice), 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 health, an incentive and recognition program, and 401K contribution (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.