Quality Assurance Specialist

Job Title: Specialist, QA Shop Floor

Job Location: Summit, NJ 07901

Job Duration: 06 Months

QA Shop Floor Specialist, Wed – Sat, 2nd Shift, 4:00 PM – 4:30 AM

PURPOSE AND SCOPE OF POSITION:

The Specialist is responsible for quality activities for the QA shop floor program in accordance with Client policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. This position will provide weekend coverage and may work off shift.

Knowledge, Skills, and Abilities:

• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

Education and Experience:

High School Degree required

Relevant college or university degree preferred.

Minimum 5 years relevant work experience

Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Perform QA shop floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
• Issue production batch records and product labels to Operations.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to effectively multi-task.
• Must be available for weekend and off-shift hours

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.

Below is the brief introduction of SPECTRAFORCE, the benefits we offer and the disclaimers:

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. Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA® with candidates and employees throughout their engagement with SPECTRAFORCE. http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers 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 nahr@spectraforce.com if you require reasonable accommodation.

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: $40.00/hr.