Job Title: QA Analyst IV Duration: 10+ Months Location: Hillsboro, OR
Looking for a Senior QA Professional
***Hiring one person for A shift which is Sun to Tue with alternating Wed (12-hrs each day) Working hours are 6am to 6:30pm ***
Main Purpose of the Position • Provide direct manufacturing Quality Assurance support for all GMP activities at HTO/HDC. • Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. • Assure compliance with cGMP regulations, company’s standards, and applicable Regulatory and company’s standards. • Resolve Quality Assurance issues and develop solutions for complex problems following cGMP regulations • Work independently within broad guidelines and policies.
Job Duties/Responsibilities • Provide Quality oversight to the manufacturing operations at HTO. • Initiate and close quality event records and action/assessment records as required. • Advocate for company’s mission of advancing and boldly championing diversity, equity, and inclusion • Follow company policies and procedures.
Technical Duties/Responsibilities • Maintain a state of inspection readiness. • Sign documents for activities as MQA as described by company’s policies, procedures and job descriptions. • Review batch records in the Aseptic Operations, Inspection, and Packaging areas. • Complete Additional Actions in the Discrepancy Management System as assigned. • Interact with interdepartmental contacts on discrepancy assessment and resolution. • Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. • Collaborate with departments to ensure that all review activities are executed efficiently and effectively. • Support process improvement initiatives.
Qualifications: Education, Experience, Knowledge and Skills • Bachelor`s or Master`s degree (preferably in Life Science or Engineering) with 4-7 years of experience in the pharmaceutical industry and at least 2 years in a quality role. • In-depth industry experience in aseptic GMP Drug Product filling and quality oversight for manufacturing processes and discrepancy management • Ability to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning into production space • Knowledge of cGMPs and Health Authority expectations • Experience reviewing manufacturing documentation • Ability to communicate clearly and professionally both in writing and verbally.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $41.57/hr.
