Specialist QA (JP4233)
3 Key Consulting West Greenwich, RI
Job Title: Specialist QA (JP4233) 3Key Consulting is looking for a Specialist QA ( for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA
Location: West Greenwich, Rhode Island 02817
Employment Type: Contract
Duration: 6 months with likely extensions
Business Unit: Quality Operations
This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.
Amgen’s Quality Assurance On-the-Floor program Shift 3 (4 days a week Tuesday through Friday 10 hours per day 10pm – 8am) or as needed by management to cover alternate shifts if required.
Position provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to compliance and quality systems
Responsibilities include the following:
• Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
• Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),
• Ensures that deviations from established procedures are investigated and documented per procedures.
• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alerts senior management of quality, compliance, supply and safety risks.
• Completes required assigned training to permit execution of required tasks.
• Supports Continual Improvement initiatives, programs and projects.
• Demonstrated experience providing quality oversight of a GMP biopharmaceutical manufacturing facility
• Strong organizational skills and ability to manage multiple tasks at one time
• Ability to follow assignments through to completion and meet timelines
• Strong communication skills, (both written and oral), facilitation and
• Employs risk based decision making
• Well-developed interpersonal skills
Doctorate degree OR Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience
• Knowledge of LEAN transformation and continuous improvement methodologies
• Provided quality oversight for nonconformance investigations, change control records and validations
• Demonstrated experience driving/implementing continuous improvement projects
• System knowledge and training in Trackwise, SAP, Manufacturing Execution System (MES: Werum PAS/X), and Maximo
TOP MUST-HAVE SKILL SETS:
1. Demonstrated experience providing quality oversight of a GMP biopharmaceutical manufacturing facility
2. Strong organizational skills and ability to manage multiple tasks at one time independently
3. Ability to follow assignments through to completion and meet timelines
DAY-TO-DAY RESPONSIBILITIES: On the floor coverage Non Conformance point of contact for decision making and review and approval batch record review' SOP review
EMPLOYEE VALUE PROPOSITION: Gain GMP Experience
No Quality experience frequent job changes short assignments
INTERVIEW PROCESS: initial phone interview then on site with team if potential candidate
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**