Location: Juncos, PR
Pay Rate: $31.07 / Hourly

Summary
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 CGMPs 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.

Responsibilities:

• 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.

Requirements:

• High school/GED + 4 years of Quality work experience OR  Associate’s + 2 years of Quality work experience OR Bachelor’s + 6 months of Quality work experience OR Master's Degree.
• 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.

 
 
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.