Quality Engineer

Specialist, QA Engineering

Onsite role, Warren NJ, 07059

Work Schedule : Monday - Friday, Business Hours

Duration : 12 Months

1. PURPOSE AND SCOPE OF POSITION :

The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems, review of validation and qualification documents for all equipment and facility activities.

This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

2. REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities

• Must have advanced knowledge and experience with GMP, Quality and compliance.
• Previous experience as a computer system validation / quality assurance for life sciences company regulated by

the FDA is preferred.

Advanced level experience in design of user requirement specifications, IQ / OQ / PQ protocols, user acceptance

testing and other equipment / facility qualification documentation.

Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue

Mountain RAM) and quality systems software (e.g. Veeva).

• Drives use of best practices during IT systems design, validation, and use.
• Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most

technical areas.

• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must be able to critically review investigations and reports, interpret results, and generate technical conclusions

consistent with Quality risk management principles.

• Intermediate knowledge of quality systems including CAPA, change control, and document management systems.
• Requires minimal direction to complete tasks, authority to make daily decisions that impact their team.
• Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and

productivity within the group or project.

• Consults management for advice on complex issues.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Drive strong collaboration within the site and across the network.

3. DUTIES AND RESPONSIBILITIES

Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification

documents for all equipment and facility activities; investigations and evaluation of change control.

Ensure IT systems are designed, setup and function in a GMP-compliant manner to safeguard and maintain the

safety and quality of client's products.

Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident,

change, release and deviations.

Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility

design.

Assures appropriateness of calibration / maintenance programs, validation plans, qualification protocols,

associated reports and procedures.

Support ECQ, Facilities, QC and manufacturing equipment-related investigations in ensuring appropriate and

thorough impact assessment, root cause analysis and corrective / preventive actions are documented and

implemented.

Ensures compliance with the site validation master plan, assist with facility start-up operations and product

transfers supporting the Qualification and Validation teams.

Work with Engineering / Facilities / ECQ management to ensure functional activities comply with global regulatory

requirements.

• Sponsor and support the change initiatives and the implementation of process improvement initiatives.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements.
• Support any other goals and objectives of the site Quality Assurance organization, as needed

4. EDUCATION AND EXPERIENCE (As Applicable)

• B.S. degree required.
• 8 + years of experience in the pharmaceutical or related industry required
• Equivalent combination of education and experience acceptable.

5. WORKING CONDITIONS : (US Only) :

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.

Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

Employees holding this position will be required to perform any other job-related duties as requested by management.

6. ADDITIONAL INFORMATION :

Contingent Workers whose jobs involve the operation of a vehicle or machinery, or physical presence in a

laboratory, research, drug development, or manufacturing facility are prohibited from having any amount of alcohol

or illicit drugs in their body while in the workplace or performing their job functions.

Suppliers and the Contingent Worker are responsible for insuring they are fit for all the duties of the job.

About Us : Established in 2004, SPECTRA FORCE ® 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.

SPECTRA FORCE 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 :

Benefits : SPECTRA FORCE 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.

SPECTRA FORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer : SPECTRA FORCE 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 [email protected] if you require reasonable accommodation.

California Applicant Notice : SPECTRA FORCE 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 [email protected].

LA County, CA Applicant Notice : If you are selected for this position with SPECTRA FORCE , 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 SPECTRA FORCE , 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 : $55.00 / hr.