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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.
Essential Duties and Responsibilities:
Prepares and distributes required documentation for requested production work orders.
Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements.
Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications.
Prepares customer required samples for shipment according to approved shipping instructions.
Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
Organize internal and customer approval of batch records and specs.
Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements.
Perform Line Clearance inspections of equipment and production suites.
Help identify, communicate, track and resolve document related issues with other departments and customers.
Function as one of the customer points for comments or questions pertaining to batch records.
Initiating supplier non-conformance reports and effectuates material control.
Reviews and integrates planned deviation requests into batch records when needed.
Adherence to PCI and cGMP policies, procedures, rules and regulations.
Attendance to work is an essential function of this job.
May perform label creation duties including generating computerized labels.
May perform duties of Quality Auditor as assigned by Supervisor/Manager
Required:
High School Diploma or GED
1-3 years related experience and/or training.
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
High Standard of Report Writing
Preferred:
Ability to follow instructions and respond to management direction.
Ability to work independently and/or part of a team.
Ability to display excellent time management skills.
Ability to demonstrate attention to detail.
A college degree with a concentration in a scientific discipline is preferred.
The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus.
#LI-MC1
EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED
Join us and be part of building the bridge between life changing therapies and patients.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Full Time
$51k-65k (estimate)
03/21/2024
05/20/2024
pci.com
PHILADELPHIA, PA
1,000 - 3,000
2010
Private
BILL MITCHELL
$500M - $1B
If you are interested in becoming a Quality Coordinator, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Coordinator for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Coordinator job description and responsibilities
Quality coordinators ensure that an organization's raw materials, production processes, procedures, and products or services comply with regulatory and quality standards.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Coordinator jobs
They are primarily responsible for devising priorities and standards, managing schedules to abide by the production timeline, monitoring activities, coordinating with production and quality control personnel, assessing employee performance, and thoroughly
03/17/2022: Providence, RI
Step 3: View the best colleges and universities for Quality Coordinator.