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location: North Billerica, Massachusetts
job type: Contract
salary: $50 - 55 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Job Responsibilities
Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP regulations marketed products and/or their raw materials, APIs, excipients or components.
Key Responsibilities/Essential Functions
- Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events.
- Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations.
- Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
- Review and approve protocols, validation documents, investigations and procedures.
- Approve change controls and represent Quality in Change Control Board meetings as needed.
- Provide Quality on the floor presence in support of manufacturing operations.
- Represent QA in a range of internal team meetings, processes and initiatives.
- Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates company values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- In the case of absence, reports to Manager above or a peer incumbent will function as a backup for this position.
qualifications:
Basic Qualifications
- BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
- This position is site-based and requires a presence on-site five days per week
- Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
- Routinely scheduled work, and/or work required on evenings, weekends, and or holidays and, even in adverse weather conditions to support manufacturing operations. See Essential Personnel Policy.
- Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.
- Ability to travel up to 10% domestically.
- Work Schedule is Monday - Friday 10-6pm
skills: Quality Assurance, CAPA, 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.
