Quality Assurance Compliance Specialist

Title: QA Compliance Specialist

Duration: 6 months

Location: Indianapolis, IN, 46268

This position's starting pay is: $56.00/hr.

Job Description:

The QA Compliance Specialist implements robust Quality Systems for AAA Indianapolis considering client and regulatory requirements of the organization. This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection and in the execution of health authority inspections.

Responsibilities:

• Supports the development and oversight of robust quality systems, including both implementation and operation at site level.

• Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.

• Works with the management team to implement and execute the Inspection Readiness program; including client Corporate Inspections and Global Health Authority Inspections.

• Facilitates training on all QA Compliance programs.

• Supports management to implement and maintain the following programs; Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Clients Global document assessments required to be performed at the site level.

• Contributes significantly to the site inspection preparation, program management, response and commitment process.

• Escalates high quality risks per procedure and supports agency notifications such as Field Alerts.

• Performs duties as assigned to ensure compliance to global and local regulations.

• Represent QA Compliance on project teams and in meetings.

• Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.

• Adheres to all GMP requirements.

• Other related duties as assigned.

Education:

B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.

Experiences:

8 years of experience in a GMP Biopharmaceutical environment

2 years of related experience in a Quality Assurance role

• Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues.

• Previous Quality Assurance experience required, including Data Integrity (ALCOA ) compliance.

• Previous experience in QA Compliance including self-inspections, preferred.

• Ability to apply a phase appropriate, risk-based approach to QA operational decisions.

• Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.

• Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus.

• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).

• Strong follow-up and organizational skills.

• Experience with radiopharmaceutical therapies a plus.

• Direct experience reviewing and/or authoring standard operating procedures.

• Ability to work well independently and within a team.

• Excellent oral and written communication skills with technical writing experience required.

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.