Quality Coordinator

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:

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.

SUPERVISORY RESPONSIBILITIES:

No Supervising of employees.

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.

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. Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.

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 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 noise level in the work environment is usually 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.

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., TrackWise). 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.

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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.