Quality Assurance Incoming Inspector Lead

Responsibilities include oversight of Incoming QA activities and providing direction for cGMPs to incoming inspectors. The Lead Inspector will have 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.

The impact of the quality inspection process directly impacts on company compliance with regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to inspection. Other duties may also be assigned.

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,

Responsible for overseeing the reject cage and supporting efforts to move and review nonconforming bulk products, components, and materials.

Responsible for ensuring and enforcing 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.

Responsible for assuring components and bulk products are sampled using the guidelines established in the standard operating procedures or item specifications.

Responsible for understanding how the equipment works and for the review of audit trails on the FT-IR, Keyence, and Global Vision.

Responsible for creating and sending Non-Conformance reports to Procurement or the customer if required.

Responsible for participating in internal and external audits at the discretion of senior management.

Responsible for timely review and approval of all Incoming Inspection documentation for approval of any packaging component or bulk product.

Responsible for coordinating the pulling of any samples that may be requested by the internal or external customers.

Responsible for working with the external laboratories to get quotes for components that need analytical testing.

Responsible for responding to any verbal or written inquiries.

Responsible for providing 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. The individual must pass a colorblindness test to assure they can detect if a color is out of specification. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• Bachelors 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.

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.
• 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)

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages, and decimals. Basic math skills (addition, subtraction, multiplication, and division) are required.

LANGUAGE SKILLS:

Ability to read and interpret common scientific data. Ability to respond to common inquiries from customers and other departments. Ability to direct and respond to inquiries from management, peers, and subordinates. Ability to effectively present information to the following groups:

• Internal: Daily contact with Quality, Operations, Material Management and Account Management department associates for information exchange, collaboration, problem solving, and direction regarding the incoming inspection process and cGMP issues.
• External: Frequent contact with customer and vendor representatives concerning activities related to the incoming inspection process which include but are not limited to specification requirements, inspection results and nonconformance reporting.

WRITTEN SKILLS:

Ability to provide clear, concise, and legible documentation within batch records, forms, and/or memos to file in conformance with basic Good Documentation Practices. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.

The noise level in the work environment is usually moderate.