Quality Assurance Incoming Inspector Lead

Responsibilities

• Oversight of Incoming QA activities and providing direction for cGMPs to incoming inspectors.
• Frequent contact with QA representatives from customers and vendors as well as internal Production, Warehouse, Sales, Materials Management, Procurement and Quality Assurance associates concerning incoming inspection activities.
• Participate in audits by customers and other regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for the oversight of inspection related tasks.
• Responsible for the distribution and assignment of inspection tasks across the designated team on the assigned shift to meet all production requirements.
• Oversee the reject cage and support efforts to move and review nonconforming bulk products, components, and materials.
• Ensure and enforce GMP compliance (including but not limited to gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout the inspection and warehouse areas.
• Ensure components and bulk products are sampled using the guidelines established in the standard operating procedures or item specifications.
• Understand how the equipment works and review audit trails on the FT-IR, Keyence, and Global Vision.
• Create and send Non-Conformance reports to Procurement or the customer if required.
• Participate in internal and external audits at the discretion of senior management.
• Timely review and approve all Incoming Inspection documentation for approval of any packaging component or bulk product.
• Cover coordination of pulling any samples that may be requested by the internal or external customers.
• Coordinate with external laboratories to get quotes for components that need analytical testing.
• Respond to any verbal or written inquiries.
• Provide monthly KPI metrics to Quality Management.
• Assist with training new hires.

Supervisory Responsibilities

• On a full-time basis oversee the incoming activities of the assigned inspection team on their shift to assure timelines are met.

Qualifications

• Bachelor's degree with minimum of four years GMP Quality experience.
• Associate degree with minimum of six years of GMP Quality experience.
• High School diploma, or equivalent with at least eight years of GMP Quality experience.
• Experience in medical device or pharmaceutical environment preferred.
• ASQ Quality Improvement Associate or Quality Inspector Certification, preferred.
• Knowledge of cGMP (21CFR 210, 211, 820), and Quality procedures.
• Knowledge of DEA regulations for controlled substances.
• Attention to detail.
• Strong communication skills (verbal and written), interpersonal skills, team building and organizational skills.
• Ability to read the English language and follow verbal and written instructions.
• Skill and ability to perform work in a thorough and accurate manner.
• Ability to use a wide variety of test and measurement equipment.
• Ability to follow and comply with procedures.
• Ability to develop and produce reports and documentation.
• Ability to work overtime (weekend – Saturday and/or Sundays).

Education and Experience

• Bachelor's degree with minimum of four years GMP Quality experience.
• Associate degree with minimum of six years of GMP Quality experience.
• High School diploma, or equivalent with at least eight years of GMP Quality experience.

Preferred Skills/Abilities

• Knowledge of cGMP (21CFR 210, 211, 820), and Quality procedures.
• Knowledge of DEA regulations for controlled substances.
• Attention to detail.
• Strong communication skills (verbal and written), interpersonal skills, team building and organizational skills.
• Ability to read the English language and follow verbal and written instructions.
• Technical writing skills are desired.

Reasoning Ability

• A thorough understanding of each aspect of the job is required.
• Ability to make rational decisions pertaining to quality compliance.
• Ability to resolve problems effectively and efficiently.

Computer Skills

• Must be proficient in Basic Windows applications such as Microsoft Office Suite.
• Familiarity with Smartsheet, Veeva and QAD desired.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• The employee frequently will sit to complete paperwork.
• The employee is occasionally required to stand, walk, and reach with hands and arms.
• The employee must occasionally lift and/or move up to 25 pounds.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• The working environment is clean and not normally subject to hazardous environment or conditions.
• The noise level in the work environment is usually moderate.