Supervisor, Drug Product Visual Inspection

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Summary of Objective:

This role is responsible for supervising visual inspection technicians to support daily operations for visual inspection, packaging and labeling of both clinical and commercial products following cGMP's and in-house SOP's. The supervisor schedules and supports daily operations for visual inspection technicians, prepare and oversee production activities, and assign personnel tasks in order to meet production schedule demands. They are expected to stay current on industry trends, inform team members of new policies and procedures, and display the highest level of integrity. This individual to possess strong people skills with the ability to organize, lead, and develop team members and has the ability to delegate tasks. A strong candidate for this position is a value-based leader who is quality driven, people oriented, has the ability to multitask a variety of projects, and works well in a dynamic work environment.

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.

• Provides technical support, training, leadership and guidance to all Visual Inspection Technicians

• Oversees areas with the responsibility of examining materials and product for quality and defects

• Early detection, troubleshooting, and escalating of problems which arise on the floor to prevent downtime. Communicates product quality issues to VI Manager and Quality Management.

• Supports Quality System Event investigations (Event Reports / Deviations / CAPAs) by collaborating with employees involved and investigating non-conformities associated to Visual Inspection, Packaging, and Labeling process.

• Responsible for creating and/or revising documents within Master Control (Standard Operating Procedures, Product Specifications, Material Control Procedures)

• Authors or reviews technical protocols to support method development or process validation

• Manages, creates, plans and maintains metrics relating to defect rate, inspection throughput, and on-time and right first time delivery

• Ensures visual inspection process and operator qualification process maintains compliance to applicable regulatory markets

• As needed participates in audits by customer and regulatory bodies as the Visual Inspection SME

• Increases efficiency and productivity by promoting systems, training, and proper record keeping

• Maintains compliance of company policies, safety standards, quality specifications and regulatory requirements

• Creates and maintains training criteria within Master Control, and performs new employee training

• Supports development and tracking of metrics (KPI's) relating to defect rate, inspection throughput, on time delivery and right first-time.

• Provides a high level of communication to VI Manager

• On the floor SME for all department-related production equipment

• Development of Visual Inspection team through individual reviews, goals and objectives. Writes annual performance reviews and manages direct reports. Act as trainer and coach for direct reports and support career growth and development and/or job satisfaction.

• Other duties, as assigned, or as business needs required

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)

• Able to communicate effectively and train others

• Able to deal with ambiguity

• Able to translate ideas to actual concepts and processes

• Proven ability to manage multiple projects simultaneously

• Able to follow written instructions

• Able to work as a team

• Lifting up to 20 pounds

• Sitting for long periods of time >50%

• Walking, standing, bending, stooping and kneeling <25% of the time

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.

• Works closely with Manufacturing and Quality departments

• Communicates daily assignments and provides clarification of operations to Visual Inspection Team.

• Escalates any product quality related issue real time to Visual Inspection Manager or VP Operations

• This individual will interact with all personnel within a variety of departments such as: Manufacturing, Quality, Materials Management, Validations, Engineering, and Facilities as required.

• Manage up to 10 Direct / Indirect Reports

• Expected to travel between manufacturing 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.

• +5 years of experience with inspection and manufacturing equipment and processes that comply with regulatory requirements.

• Relevant industry experience in sterile product manufacturing or visual inspection (3-5 years) or related experience

• Experienced with GMP's, SOPs and working within an FDA / EU regulated environment.

• Experience with eQMS, Master ControlTM is a plus

• Experience with Visual Inspection and or labeling and packaging of Pharmaceutical final products, medical device, and/ or combination products a plus

• Prior laboratory experience a strong plus

• AS/BS degree in related field is highly preferred.

• High school diploma or equivalent is required

• Proficient with MS Office (Word / Excel / Access)

• SME in Visual Inspection of large and small volume parenteral, both Liquid and Lyophilized presentations

• Maintains a high level of integrity while balancing all job responsibilities

• Ability to coach, train and mentor employees

• Strong written and verbal communication skills

• Ability to read, understand, follow and comply with technical and written documents (SOPs) in English

• Team oriented and highly collaborative

• Self-motivated, proactive in identifying product quality issues or employee performance issues

• Maintains a high level of integrity while balancing all responsibilities

• At ease building rapport 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

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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.