In support of company Quality Assurance program, we are seeking a highly motivated and talented staff to join us as Sr. Associate QA, to support and oversee the activities of the Plant Quality Assurance department in our inspection and packaging facility located in Juncos, Puerto Rico.
A strong foundation in application of GMPs in a drug product manufacturing environment is critical, to quickly assess facts and make the appropriate decision when process/product quality may be impacted.
The selected individual will perform sampling plans for all drug products, batch record review, audit the inspection and packaging process ensuring compliance to procedures and Quality standards as well as oversee aspects of QA operations within the facility, including but not limited to on-the-floor QA support, deviation investigations, change controls, and SOP revisions.
Functions
Perform sampling plans for all manufactured products.
Perform batch record review.
Perform SAP transactions.
Perform Trackwise system queries, deviations.
Participate in triage process.
Perform oversight of the process and procedures/GMP tasks.
Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies.
Participate in internal plant audits.
Work with operations to resolve basic compliance discrepancies.
Assist in Investigations.
May perform work of Associate QA.
Education:
High school/GED + 4 years of Quality work experience OR Associates + 2 years of Quality work experience OR Bachelors + 6 months of Quality work experience OR Master's
Skills:
Experience in QA Acceptance Sampling Plan Inspection
Execution/documentation in Electronic Batch Record
On line Batch Record Review
Quality Oversight of the Inspection processes
Knowledge of SAP system
Basic statistical mathematical skills.
Basic knowledge of process and facility equipment.
GMP knowledge with ability to interpret and apply in routine cases.
Technical writing capability.
Demonstrated skill in problem solving and providing solutions.
Ability to interface effectively with various levels.
Basic understanding of analytical methods used in support of facility process monitoring.
Self-motivated.
Ability to work as a team player and/or independently.
Ability to evaluate documentation/ operations according to company guidelines.
Intermediate word processing, database, presentation and spreadsheet application skills.
Skill in prioritizing and meeting deadlines.
Good communication and presentation skills (both written and verbal)
Independently understand, follow and implement instructions.
Ability to seek outside resources as needed.
Demonstrate the company Values.
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 health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation 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 benefits_pr@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: $31.07/hr.
