Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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 Lead inspector will set an example by staying current on industry trends, informing team members of new policies or procedures and displaying integrity. Possess strong people skills with the ability to organize team members and delegate tasks. The team leader will serve as a link between team members across two manufacturing sites and Visual Inspection Management. They must be knowledgeable, kind, and a professional role model in order that team members respect their judgment. Must be responsible, dependable, self-motivated, pro-active and provide suggestions for improvement. Responsible for performing 100% manual visual inspection, labeling and packaging of sterile filled containers (vials) in accordance with all applicable procedures, regulations and safety directives across multiple sites.
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.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice. Supports Visual Inspection, Packaging and Labeling of product as needed across multiple sites with minimal to no supervision.
- Follows written procedures as well as documentation of results in a neat and precise manner according to GMP standards and other regulations
- Monitor workers on site during production activities to ensure adherence to ethics and safety procedures
- Motivate workers to enhance production quantity and at the same time maintain high production standards
- Collaborate with management to create work schedule for workers and ensure that it is within process capabilities.
- Initiates Quality System Event investigations (Event Reports / Deviations / CAPAs) and works with management to determine probable root causes
- Perform document changes within the Master Control system
- Review protocols and manufacturing batch records; provide insight for process improvements.
- Supports development and tracking of metrics (KPI’s) relating to defect rate, inspection throughput, on time delivery and right first-time.
- Train new employees on visual inspection requirements of liquid and lyophilized final vial product.
- Support management with the development and maintenance of visual inspection qualification test kits as applicable.
- Assist management with the execution of protocols and additional projects in a timely manner
- Lead workers set an example by staying current on industry trends, informing team members of new policies or procedures and displaying integrity.
- Work as middleman between workers and management to create healthy communication. Serve as a guide to answer questions, offer insight and organize responsibilities.
- Utilizes knowledge and experience to identify potential issues and works with management to gain resolution
- Supports the overall performance of team members toward meeting group objectives
- Demonstrates the ability to maintain attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines.
- Other duties, as assigned, or as business needs require
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.
- Must be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products
- Must be able to work while wearing required PPE for all GMP areas for an entire shift. (Includes non-latex gloves, hair\beard covers and lab coats)
- Walking, standing, bending, stooping, kneeling < 25% of the time
- Sitting 50% of the time; Driving Occasional <25%
- Able to communicate effectively and train others
- Able to deal with ambiguity
- Able to translate ideas to actual concepts and processes
- Able to follow written instructions
- Ability to read, understand, follow and comply with technical and written documents (SOPs) in English
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.
- Leads team by supporting daily assignments and providing clarification when needed to Visual Inspection Team.
- Escalates any product quality related issue real time to Visual Inspection Management
- This individual will interact with mid-level personnel within a variety of departments such as: Operations, Quality, Validations, and Facilities as required.
- TRAVEL – Expected to travel between facilities to carry out duties
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.
- 3-5 years of experience with inspection and manufacturing equipment and processes that comply with regulatory requirements.
- Experienced with GMP’s, SOPs and working within an FDA / EU regulated environment.
- Experience with Visual Inspection and or labeling and packaging of Pharmaceutical final products, medical device, and/ or combination products a plus
- Prior lab experience a strong plus
- High school diploma or equivalent required
- Relevant industry experience in sterile product manufacturing or visual inspection (3-5 years) or related experience.
- Team oriented and highly collaborative
- Strong initiative for quality driven results
- Maintains a high level of integrity while balancing all responsibilities
- Works with multiple departments to achieve company goals and objectives
- Highly attentive and organized with documentation
- Strong commitment to excellence and quality with a positive working attitude
- Proficient with MS Office suite (Word / Excel / Access).
- Ability to understand VI Concepts, methodologies and regulations.
- Ability to recognize and communicate quality issues to multiple groups
- Ability to motivate, train less experienced staff.
- Exceptional communication skills both verbal and written.
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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, 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.
