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:

This position is responsible for providing the direction, training, organization, alignment, and monitoring of all cGMP processes that occur on the production floor. This individual will be expected to coach, mentor, and train the Quality Auditors in order to ensure that they are knowledgeable and capable of ensuring the highest level of Quality while simultaneously ensuring that all of our processes are cGMP compliant.

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.

Coach, mentor and train the Quality Auditors and Label Room Personnel in order to develop them from a Quality and cGMP perspective.

-Assess risks in accordance with the guidance delineated in ICH Q9, ISO, 21CFR, and EU guidelines and develop robust and sustainable solutions.

-Audit the production suites, analyze the processes and implement robust and sustainable Quality

Improvements.

-Conduct internal audits of facility, production floor, equipment, and warehouse and provide written reports summarizing findings.

-Perform periodic reviews of the batch record throughout the production operation to ensure cGMP compliance and completion and accuracy of the auditor findings.

-Provide guidance and support of the Quality Auditors and the Operations staff whenever challenges and/or inspections do not pass; ensure that impacted material is appropriately quarantined during these events and management notified.

-Partner with Operations to train, mentor, and coach the production personnel to help facilitate the understanding of cGMP and statutory requirements.

-Observe and correct any Quality deficiencies on the production floor or in individual packaging suites.

-Highlight Quality and Operational improvements to foster an environment of proactive and

continuous process improvement.

-Act as "back up" for any Quality Auditor during times of vacation or absence.

-Ensure the creation of shipper labels is compliant with Regulatory, customer, and PCI requirements.

-Perform other duties as assigned by Director of Quality Operations.

SUPERVISORY RESPONSIBILITIES:

Supervision, management, and training of Quality Auditors across all three shifts as well as Label Room personnel.

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 of performing 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 of performing the above duties with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or listen. The employee is frequently required to stand and walk. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.

WORK ENVIRONMENT:

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.

EDUCATION OR EQUIVALENT:

-Bachelor's degree in scientific discipline (i.e., Biology, Chemistry, Physics, etc.) or equivalent experience

-Proved ability to lead, train and mentor.

-Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred.

LANGUAGE SKILLS:

-Must possess good analytical skills and excellent verbal and written communication skills.

-Must demonstrate effective listening, coaching and interpersonal communications skills.

KNOWLEDGE/SKILLS REQUIREMENTS:

-Must be dependable and show initiative to improve safety, quality, throughput and cost performance.

-Must be willing to be flexible with working on all 3 shifts as needed for training and development of staff.

-Able to balance multiple issues simultaneously in a fast-paced environment.

-Needs good problem-solving skills, should be detail oriented and well organized.

COMPUTER SKILLS:

-Must be computer literate with experience using MS Office, Lotus Notes, spreadsheets, and ERP systems.

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.