Quality Assurance

Location: Barceloneta, PR

Overview: As a Quality Assurance Associate at [Company Name], you will play a key role in ensuring that our pharmaceutical products meet regulatory requirements and adhere to quality standards. You will work closely with cross-functional teams to implement and maintain quality systems and processes throughout the product lifecycle.

Key Responsibilities:

1. Conduct routine inspections and audits of manufacturing processes, facilities, and documentation to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulations.
2. Review batch records, production documents, and quality control test results to verify product quality and compliance with specifications.
3. Assist in the investigation of deviations, non-conformances, and customer complaints, and collaborate with relevant departments to implement corrective and preventive actions (CAPAs).
4. Participate in the review and approval of validation protocols, master batch records, and standard operating procedures (SOPs) to ensure accuracy and compliance with regulatory requirements.
5. Support internal and external audits by regulatory agencies or third-party auditors, and contribute to the development and implementation of audit responses and corrective actions.
6. Provide training to employees on quality procedures, regulations, and documentation requirements to promote a culture of quality and compliance.
7. Maintain documentation and records related to quality assurance activities, including batch records, inspection reports, and CAPA documentation, in accordance with company policies and regulatory guidelines.
8. Stay current with developments in regulations, guidelines, and industry best practices related to pharmaceutical quality assurance, and proactively recommend improvements to quality systems and processes.

Qualifications:

• Bachelor's degree in a scientific or engineering field, preferably in pharmacy, chemistry, biology, or related discipline.
• [Specify any required certifications or licenses, if applicable.]
• [Specify any required years of experience in pharmaceutical quality assurance or related field.]
• Strong knowledge of GMP, GLP, and other relevant regulatory requirements for pharmaceutical manufacturing.
• Excellent attention to detail and analytical skills, with the ability to interpret and apply complex regulations and guidelines.
• Effective communication and interpersonal skills, with the ability to collaborate across departments and communicate effectively with internal and external stakeholders.
• Ability to work independently and prioritize tasks in a fast-paced environment, while maintaining a focus on quality and compliance.
  
  Note: This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Duties, responsibilities, and qualifications may be adjusted as needed to meet the evolving needs of the company.

 

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. 
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: $26.00/hr.