Quality Assurance Incoming Inspector Lead

Sharp Packaging Services•Allentown, PA

2d•Hybrid

About The Position

This role involves overseeing 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. The position also requires participation in audits by customers and other regulatory agencies. The quality inspection process directly impacts the company's compliance with regulatory requirements and customer satisfaction.

Requirements

Ability to pass a colorblindness test to assure they can detect if a color is out of specification.
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.
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 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.
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 internal and external groups.
Ability to provide clear, concise, and legible documentation within batch records, forms, and/or memos to file in conformance with basic Good Documentation Practices.
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.
Must be proficient in Basic Windows applications such as Microsoft Office Suite.
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.

Nice To Haves

Experience in medical device or pharmaceutical environment preferred.
ASQ Quality Improvement Associate or Quality Inspector Certification, preferred.
Technical writing skills are desired.
Familiarity with Smartsheet, Veeva and QAD desired.

Responsibilities

Oversight of inspection related tasks.
Distribution and assignment of inspection tasks across the designated team on the assigned shift to meet all production requirements.
Overseeing the reject cage and supporting efforts to move and review nonconforming bulk products, components, and materials.
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.
Assuring components and bulk products are sampled using the guidelines established in the standard operating procedures or item specifications.
Understanding how the equipment works and for the review of audit trails on the FT-IR, Keyence, and Global Vision.
Creating and sending Non-Conformance reports to Procurement or the customer if required.
Participating in internal and external audits at the discretion of senior management.
Timely review and approval of all Incoming Inspection documentation for approval of any packaging component or bulk product.
Coordinating the pulling of any samples that may be requested by the internal or external customers.
Working with the external laboratories to get quotes for components that need analytical testing.
Responding to any verbal or written inquiries.
Providing monthly KPI metrics to Quality Management.
Assisting with training new hires.
On a full-time basis oversee the incoming activities of the assigned inspection team on their shift to assure timelines are met.