Job Description

The Quality Assurance Specialist reports to the Quality Manager and is responsible for the daily requests, preparation and distribution of product certifications, including electronic and manual generation and distribution of Certificates of Conformance (C of C) and Certificates of Analysis (C of A) for all Mactac products, assisting with the maintenance and processing of the document control system including manual and electronic document control files/software, procedures, record retention, change control and training records. In addition, the position is responsible for supporting the internal auditing program, assisting in the document preparation and distribution of RDT trial and standard Mactac product specifications as needed. Support role includes assisting with other clerical duties and laboratory support as required to support the Quality and Research & Development Department.

Key Responsibilities

Performs the duties consistent with the Quality Assurance Specialist including, but not limited to:

Maintain and execute requests for all product certifications, generate and maintain RDT product specifications and files, assist with document control processing and any additional Quality and Lab support as listed:

• Generation and distribution of electronic Certificates of Conformance for Mactac products
• Generation and distribution of electronic Certificates of Analysis for Mactac products
• Generation, distribution and maintenance of all manual Certificate of Conformance and Certificate of
• Analysis files
• Assist with new and revised document requests supporting Document Control
• Assist with routing, tracking, and facilitating documentation review, approval and periodic/biannual review.
• Participate and provide support for the Quality System during audits.
• Assist in the development and implementation of standards for the quality department.
• Capable of investigating, selecting, and implementing new software systems for Document Control
• and Quality data statistical analysis.
• Provide laboratory support as needed, Peels, Loop Tacks, Release, Shears and Rheology
• Some travel may be required for training and support to other Mactac locations.
• Other duties may be assigned to assist in support of the Quality group.
• Regular attendance is required.

Scope:

• Direct Reports: No

Reports to: Quality Manager

• Location: Scranton, PA

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

BS Degree in relevant scientific discipline preferred or equivalent experience level (3+ years).

• Quality Assurance experience preferred within manufacturing environment.
• Computer literate in MS Excel
• Computer literate in MS Word (Intermediate/Expert skill level)
• Computer literate in E2000 / transition to electronic Document Control System

Skills:

• Must be computer literate in Microsoft Outlook, Excel and Word.
• Requires the ability to perform basic math skills and the ability to interpret and utilize various units of measure and their conversions.
• Requires the ability to comprehend oral and written instructions and the ability to communicate effectively in oral and written form, for interaction with various individuals within the organization.
• Ability to communicate in writing and verbally within the organization and to external customers.
• Ability to follow directions with minimal supervision and be self-directed.

Work Environment:

This position normally works in an office environment, with some time spent in the manufacturing facility and laboratory. Hearing, eye, and foot protection are mandatory when engaged in activities in the plant.

Disclaimers:

• The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
• It is the policy of Mactac that all employees are employed at the will of Mactac for an indefinite period and are subject to termination at any time, for any reason, with or without cause or notice. At the same time, employees may terminate their employment at any time and for any reason.
• Equal Opportunity Employer. All qualified candidates will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, gender identify, national origin, protected veteran status, disability, age, pregnancy, genetic information, creed, citizenship status, marital status or any other consideration prohibited by law or contract.

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or Mactac and affiliated employees.