Quality Assurance Lead V

• 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

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.

Best Regards,

Sneha Shrivastava

973-967-3348