Reference #: JR102456
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.
Summary of Objective:
The Quality Coordinator role is responsible for providing the generation, review and traffic of production batch records and orders within a cGMP environment. This position ensures that operational goals and objectives of the team are accomplished within prescribed time frames and helps drive project success to provide PCI a competitive advantage in long-term quality customer management.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following:
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 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.
Prepares planned deviation requests when needed.
Adherence to PCI and cGMP policies, procedures, rules and regulations.
May prepare customer required samples for shipment according to approved shipping instructions.
Attendance to work is an essential function of this job.
May perform label creation duties including generating computerized labels.
May perform Quality Auditor duties as assigned by Supervisor/Manager.
Other duties as assigned by Supervisor/Manager.
Shift is 8:00am- 8:00pm, Friday - Sunday
Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Stationary Position: From 1/4 to 1/2 of the day.
Move, Traverse: From 1/4 to 1/2 of the day.
Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
Install, place, adjust, apply, measure, use, or signal: None.
Ascend/Descend or Work Atop: None.
Position self (to) or Move (about or to): Up to 1/4 of the day.
Communicate or exchange information: 3/4 of the day and up.
Detect, distinguish, or determine: 3/4 of the day and up.
On an average day, the individual can expect to move and/or transport up to 10 pounds: less than 1/4 of the day.
This position may have the following special vision requirements.
Ability to 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. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for: up to 1/4 of the day.
Work is primarily performed at a desk and/or in an office environment: for 1/2 to 3/4 of the day.
The noise level in the work environment is typically: Moderate.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
High School Diploma or GED and 1-3 months 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.
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.
Preferred:
College degree preferred.
JDE and/or other ERP system management.
Current experience in performing documentation review.
Operational Quality experience within a cGMP environment.
EQUAL OPPORTUNITY EMPLOYER/DISABLED/VET
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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
