Sr.Quality Assurance Associate

Artech Information System LLC; Baltimore (MD); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading IT staffing company is seeking a Senior QA Associate to ensure compliance with quality standards in the pharmaceutical sector. The role requires 8+ years of experience in Quality Assurance, including batch record review and deviation investigations. Strong interpersonal, communication, and organizational skills are essential. The candidate will work with minimal supervision to conduct compliance reviews and collaborate with production units. This is a critical position located in Baltimore, MD.

Qualifications

• 8+ years of senior level experience in Quality Assurance within the pharmaceutical or closely related industry.
• Demonstrated experience performing batch record review and disposition.
• In depth knowledge of CGMPs and Regulatory Guidelines.

Responsibilities

• Conduct compliance review of peer's work before management approval.
• Determine product compliance with manufacturing standards.
• Review executed commercial production records for GMP compliance.

Skills

Interpersonal skills

Communication skills

Organizational skills

Critical thinking

Attention to detail

Education

BS/BA or MS in Chemistry or closely related field

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill‑sets availability, deliver emerging technology skill‑sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• The position is critical to ensuring that Organizational, Site, and Departmental objectives and goals such as Uninterrupted Supply of Product and a Responsive Supply Chain are obtained.
• The Senior QA Associate is an individual contributor with no direct reports.
• Senior QA Associate receives no instruction on routine work as these asks are described in detail in established procedures and standards.
• Receives general instructions on new assignments.
• Provides an independent compliance review of their peer's work prior to final management approval.
• May work on problems and investigations of diverse scope where they exercise judgment within generally defined practices and policies, knowledge of CGMP, job‑related experience.
• They independently determine whether the product manufactured by Client meets standards and is acceptable for distribution to Client patients.
• The Senior QA Associate is expected to perform their core job functions with minimal supervision and input from management.
• Reviews executed commercial production records in a timely manner, ensuring that records are in compliance with GMP's and standard operating procedures.
• Upon completion of review, assigns the appropriate disposition.
• Functions as a subject matter expert for the QA department.
• Represents QA on cross‑functional department teams and serves as group leader in the absence of department manager.
• Conducts, writes and performs risk assessments for investigations/deviations in collaboration with the production unit to fully understand the impact of any deviation.
• With assistance from the production unit, determines root cause and assigns appropriate CAPA.
• Product Complaints contacts customers, conducts and writes investigation, trends complaints, collaborates with the production unit to fully understand the impact of the complaint, and with assistance from production unit determines/assigns appropriate CAPA drafts or contributes to QA documentation, including investigation reports, standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data.
• Other duties as assigned to facilitate ongoing Client Baltimore/Gliadel production and/or operational activities including, but not limited to involving Client‑Baltimore, ECL, and external partners and companies.
• Review Out Of Calibration report, weekly alarm trends and Labeling change controls.
• Executes AQL inspections and sampling performs Area Clearance and In Process inspections to support Gliadel production.
• Periodically summarizes status and progress of assigned activities as requested by supervisor.

Qualifications

• BS/BA or MS in Chemistry, or closely related field required.
• 8+ years of senior level experience in Quality Assurance within the pharmaceutical or closely related industry. Prior supervisory experience preferred, but not required.
• Demonstrated experience performing batch record review and disposition, investigating product complaints and conducting deviation investigations.
• In depth knowledge of CGMPs and Regulatory Guidelines.
• Strong interpersonal and communications skills (oral and written) required.
• Demonstrated excellent customer service skills in dealing with external clients.
• Demonstrated organizational skills.
• Critical thinking and effective decision making skills with ability to identify issues requiring further attention, and ability to initiate and facilitate resolution of those issues in a timely & professional manner.
• Strong attention to detail.

Additional Information

This is a time sensitive and critical position a quick response would be of great help.

Contact Information:
Sneha Shrivastava
Technical Recrutier
[phone]