Quality Assurance Lead V

Artech Information System LLC; Canton (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading IT staffing company in Massachusetts is seeking a qualified individual to investigate GMP operations and ensure compliance with regulations. The ideal candidate will have a Master’s or Bachelor’s degree in Engineering or Life Sciences, coupled with extensive experience in Quality and Compliance within the biotechnology or pharmaceutical sectors. Strong investigation, analytical, and leadership skills are essential. The role involves ensuring inspection readiness and supporting audits. Competitive salary and benefits offered.

Qualifications

• Master’s Degree in Science and 5 years of relevant industry experience.
• Bachelor’s Degree in Science and 7 years of relevant industry experience.
• 12+ years relevant industry experience with biologics or pharmaceuticals.

Responsibilities

• Investigate GMP operations deviations and make recommendations.
• Ensure inspection readiness and compliance with CGMP regulations.
• Lead investigation teams and assist in tracking CAPAs.
• Provide support during audits and address observations promptly.

Skills

Investigation of medium and high risk events

Customer focus

CGMP compliance knowledge

Analytical skills

Organizational skills

Communication skills

Interpersonal skills

Leadership abilities

Decision making skills

Education

Master’s Degree in Engineering or Life Sciences

Bachelor’s Degree in Engineering or Life Sciences

12+ years relevant industry experience

Tools

MS Office Applications

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

• Investigate events/ non-conformances encountered during GMP operations, such as manufacturing, testing or holding of drug products.
• Partner with operation; work on the shop floor and in a team environment to provide on the spot input and guidance in responding to deviations. Lead investigation teams.
• Make recommendations to department management regarding results of investigation and process improvements, when necessary.
• Work with impacted department management to identify appropriate corrective and preventive actions.
• Assist in tracking of CAPAs through completion.
• Ensure a constant state of inspection readiness ensuring that deviation and CAPA documents remain current.
• Provide support during internal and external audits and ensure that assigned audit observations are addressed quickly and completely to maintain readiness levels.
• Perform CGMP audits, as necessary. Identify and communicate CGMP compliance deficiencies to Upper Management, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented.
• Provide final signatory review for SOPs, SWIs, and Master Manufacturing Records to ensure compliance with CGMP, regulatory and internal requirements such as company guidelines and approved procedures.
• Perform special projects as assigned by supervisor.

Skills

• Experienced investigator able to effectively investigate medium and high risk events
• A strong customer focus and ability to prioritize and adapt to compliance and business needs are required
• Experience in maintaining CGMP compliance
• Excellent organizational, analytical, and problem solving skills
• Balanced decision making skills
• Strong communication skills with the ability to interact with all levels throughout the organization
• In addition, demonstrated excellent interpersonal skills and flexibility
• Must have understanding and/or working knowledge of CGMP regulations
• The ability to apply quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities
• The ability to work effectively and efficiently in a cross functional team environment
• Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
• Experience interacting with regulatory agencies and health authority inspections is preferred
• Excellent organizational, interpersonal and leadership/teamwork abilities are required
• Strong GMP background including working knowledge of GLP/GMP
• Diverse business, quality, and industrial manufacturing knowledge base

Qualifications

Education:

• Master’s Degree of Science in Engineering or Life Sciences and 5 year of relevant industry experience

OR

• Bachelor’s Degree of Science in Engineering or Life Sciences and 7 years relevant industry experience

OR

• 12+ years relevant industry experience

• Demonstrated experience with MS Office Applications
• Significant experience leading Problem Solving and Process Improvement teams
• Must have a minimum of 5-7 years of relevant experience within Quality, Compliance, or manufacturing
• Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience.