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.
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 in order to train, mentor, and coach the production personnel in order to help facilitate the understanding of cGMP and statutory requirements
 Observe and correct any Quality deficiencies on the production floor or in individual packaging suite
 Highlight Quality and Operational improvements in order 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

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 in regard to 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.

LI-KH1

Join us and be part of building the bridge between life changing therapies and patients.
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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.
At PCI, Diversity, Equity, and Inclusion (DEI) 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

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 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 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 sit. The employee is occasionally required to stand; walk. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.