Live Chat
Contact

QC Associate II Job in Wilmington, Ohio US

QC Associate II

Alkermes, Inc. - Wilmington, OH

Posted: 5/10/2021 - Expires: 8/8/2021

Job ID: 227126648

Print 

Job Description

QC ASSOCIATEII

The QC Associate II is responsible for sampling and inspecting for quality incoming raw materials such as active pharmaceutical ingredients, excipients, components, and processing aids. This role is also responsible for creating or revising documents in Alkermes' quality systems such as change controls, deviations, supplier nonconformances, standard operating procedures, and specifications.

MAJOR RESPONSIBILITIES

Review documentation such as Certificate of Analyses, assign expiration and retest dates for incoming raw materials

Coordinate the sampling of all incoming raw materials and components

Collaborate with Supply Chain, Warehouse, Receiving, Quality Assurance, Operations and the testing laboratory in order to schedule activities.

Log samples into Laboratory Information Management System (LIMS), assign testing requirements and enter analytical results

Verify raw material labeling such as part and lot numbers

Inspect containers for defects and damage

Clean sampling equipment and any associated sampling areas

Operation of equipment such as gloveboxes, fume hoods, bio safety cabinets and balances

Perform sampling for all raw materials, active ingredients, excipients, components, processing aids etc.

Follow written procedures for sampling techniques and requirements.

Perform the visual inspection and dimensional testing of components

Operation of equipment such as calipers, tape measure, gauge blocks and sight gauges

Identify non-conforming materials at any point in the process

Coordinate retain program

Prepare and maintain retain samples for raw materials

Receive and maintain finished product retain samples

Plan, schedule and execute periodic retain inspections in compliance with written procedures for both raw materials and finished products

Perform disposals of both raw materials and finished products when appropriate

Write the retain inspection assessment report

Review work of peers, as needed

Create and revise standard operating procedures, technical reports, and specifications, as required

Write supplier non-conformances

Write change controls

Create discrepancy reports and perform Root Cause Analyses

Train other colleagues in methods and procedures

Leads project improvements

Participates in regulatory and internal audits

Works in a safe compliant manner

Use electronic document, inventory and maintenance systems

LIMS

SAP

Veeva

Microsoft Word

Microsoft Excel

Maximo

PowerPoint

TrackWise

EMC ApplicationXtender ((AX) - Scanned Document Library))

NuGenesis SDMS - Scientific Data Management System

PREFERRED SKILLS/ABILITIES

Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts.

Able to handle multiple projects with competing priorities.

Intermediate skills in computer use with ability to learn and master new computer applications.

Self-directed and motivated, detail oriented, quality-minded with strong organizational skills.

Effective oral and written communication skills

Able to follow written procedures and exhibit excellent documentation practices.

Able to take on additional tasks, as required.

Able to lift 50lbs

Work well independently or with a group

Able to work safely; seek out and encourage safe practices

Able to pass an eye exam for visual inspection

REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in a scientific discipline with 0-2 years' experience in a quality department

Or

Associate Degree in a scientific discipline with 5+ years' experience in quality department

Or

10+ years' experience in a quality department

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

#LI-DB1




 Experience Level:
Associate

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Associate's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
54535428
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A