Quality Coordinator

LSNE Contract Manufacturing • Philadelphia, PA • 3h ago

Reference #: JR117250 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.

Job Description

Summary of Objective: 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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

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 completed orders and orders in process to ensure compliance with cGMP's and customer requirements.

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.

Attendance to work is an essential function of this job.

May perform duties of Quality Auditor as assigned by Supervisor/Manager.

Other duties as assigned by Supervisor/Manager.

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 AND/OR EXPERIENCE: High school education and experience working in a cGMP environment. A college degree with a concentration in a scientific discipline is preferred. Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines. The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Mastercontrol). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus.

LANGUAGE SKILLS: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to management and customers. Must have strong interpersonal and excellent communication skills.

MATHEMATICAL SKILLS: Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

COMPUTER SKILLS: Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project.

LI-DT1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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.

Similar Jobs

Sr Director, State Government Affairs (Remote)

Cengage Group • Philadelphia, PA • 2h ago

We believe in the power and joy of learning At Cengage Group, our employees have a direct impact in helping students around the world discover the power and joy of learning. We are bonded by our shared purpose - driving...

2h ago

Go to Apply

Lead Software Engineer

Ampcus Inc. • Philadelphia, PA • 2h ago

IT & Engineering

Reference #: 26-04551 Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: Lea...

2h ago

Go to Apply

Principal Software Engineer I

ERT • Philadelphia, PA • 2h ago

IT & Engineering

Reference #: R16873 Clario is a global leader with more than five decades of experience advancing clinical trial technology. Our solutions streamline evidence collection, improve data accuracy, and accelerate decisionmak...

2h ago

Go to Apply

Software Engineer, Senior

Booz Allen Hamilton INC. • Moorestown, NJ • 2h ago

IT & Engineering

Job Number: R0236058 Software Engineer, SeniorThe Opportunity:As a full stack developer, you can resolve a problem with a complete end-to-end solution in a fast, agile environment. If you're looking for the chance to not...

2h ago

Go to Apply

Senior Director, HR Operations

LSNE Contract Manufacturing • Philadelphia, PA • 3h ago

Reference #: JR117247 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...

3h ago

Go to Apply

Director, Human Resources

LSNE Contract Manufacturing • Philadelphia, PA • 3h ago

Management & Administrative

Reference #: JR117278 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...

3h ago

Go to Apply

IT Specialist (61359)

Adams and Associates • Philadelphia, PA • 4h ago

IT & Engineering

Salary Range $34.35 - $34.35 Hourly Position Type Full Time Education Level High School Category Information Technology Description "Are you someone who thrives on solving problems and helping others succeed through smar...

4h ago

Go to Apply

Customer Service Representative

TEKsystems • Plymouth Meeting, PA • 4h ago

Management & Administrative

Description This position will work in a call center environment, working directly with our plan sponsors by answering incoming emails and calls, utilizing company policies to solve client issues, and escalating challeng...

4h ago

Go to Apply

Customer Service Associate

Wawa, Inc. • Morton, PA • 4h ago

Management & Administrative

As a Customer Service Associate (CSA) you are the friendly face that puts the 'Wow' in Wawa by greeting and serving our customers. As a CSA, you are proud to be part of a beloved brand that is committed to putting people...

4h ago

Go to Apply

Construction Manager

Hill International, Inc. • Philadelphia, PA • 5h ago

Trucking & Construction

Reference #: 13667 Hill International is seeking a Construction Manager in the United States. Oversee the activities of the consultant team, including the Construction Management Consultant (CMC) or Design-Build Project...

5h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.