100% onsite ***This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:50 AM – 7:00 PM ***
Ideal Candidate: GMP experience is a must, drive, Independent but able to work within a team structure, Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams), Knowledge of data integrity requirements, Excellent written and verbal communication skills.
Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
Responsibilities Include the Following: Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations. Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations. Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation. Ensure that deviations from established procedures are documented per procedures. Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements. Alert management of quality, compliance, supply and safety risks. Complete required assigned training to permit execution of required tasks. Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls. Communicating and collaborating with the PQA shift to ensure required tasks are completed
Day to Day Responsibilities: 1)Quality Oversight (including Purposeful Prescence on the Floor) of bulk drug substance manufacturing operations 2)GMP documentation review/approval (including EURs, electronic logbooks, RT reports, Work Orders, batch records, etc.) 3)Interim and reject cage management
Basic Qualifications: -High school/GED + 4 year work experience OR Associate + 2 years work experience OR Bachelor + 6 months work experience Master's
Top 3 Must Have Skill Sets: 1) cGMP experience 2) Experience collaborating within and across functional areas and demonstrated customer service focus 3) Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
Preferred Qualifications: Bachelor’s degree and 2 years of Quality/Manufacturing work experience Experience working in a cGMP environment Experience with decision making Experience with analytical testing and/or general compendia testing Experience working with batch records and other GMP documentation Knowledge of data integrity requirements Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams) Experience collaborating within and across functional areas and demonstrated customer service focus Excellent written and verbal communication skills Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
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: $29.00/hr.
