- 195094 - Compliance Specialist II
- Up to $110.00 DOE
- 3 months
- Chipton-Ross is seeking a Compliance Specialist II for an opening in Lexington, MA.
• Provide quality oversight of facility/utility and equipment for qualification activities.
• Review all qualification documents for equipment and systems such as URS, DQ, SAT, FAT, design documents and protocols (IQ, OQ & PQ).
• Carry out duties in compliance with all local, state, and federal regulations and guidelines including the FDA and EU.
• Comply with all global and site policies and procedures.
• Provide technical support on change controls, assessing new change controls for process equipment, utilities and automation systems that are proposed and all the requirements necessary to maintain a validated status.
• Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary reports.
• Support review and approval of generation of quality assurance policies and procedures
• Support, interpret and implement quality assurance standards
• Participate in all aspects of QAV operations within the facility, to support deviation investigations, change controls, customer quality support and SOP review.
• Provides Quality support to the life cycle of analytical equipment / instrumentation and analytical method validation / verification.
• The position involves close collaboration with Engineering, Manufacturing, EHS, Quality Control, and other teams to complete all responsibilities
• 3-5 years’ experience in quality and compliance for site Utilities, Equipment and Automation in a sterile environment.
• Must have strong knowledge of 21 CFR, ICH Q9, ICH Q10, ISO-14644, GAMP5, ASTM-E2500 and EU regulations
• Must be able to understand operational documents for GMP compliance, accuracy and completeness
• Experience with qualification for the following systems: WFI, Clean steam, process gases, HVAC Bioreactors, Autoclaves, Chromatography skids, Tangential flow filtration (TFF)etc.
• Experience with the qualification of single use technology is desired.
• Experience with the qualification of a drug product fill line (including isolator, filler) and Aseptic Process Simulation (APS) is desired.
• Able to plan, coordinate and perform with minimal oversight
• Strong interpersonal and communication skills.
• Strong understanding of applicable regulatory requirements (FDA and EMA).
• Ability to function in a dynamic environment and balance multiple priorities simultaneously
• Ability to make decisions with minimal to moderate supervision
• Ability to aseptically gown and /or sterile gown as needed
A B.S. degree in science/engineering field.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x254 or (800) 927-9318 x254
To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.