Job description

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 performing visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations, and safety directives. This individual’s primary job function will be to ensure finished drug product vials manufactured by PCI are free of visible defects which are culled through the visual inspection process to support patient safety and product quality. 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. Repetitive handling of sterile filled containers while primarily in a seated position, swirling and inverting containers and extending arm out in front of light source in order to identify product defects. Records production quantities and other applicable information with adherence to Good Documentation Practices Applies a moderate level of math skills to include piece counting, time calculations, and product reconciliation. Following written procedures and documents results in a neat and accurate manner according to GMP standards and other regulations. Performs daily cleaning of visual inspection and packaging areas in accordance with established procedures. Identifies and communicates product quality issues. Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines. Effectively communicates both verbally and in writing with all levels. Maintains a high level of integrity while balancing all job responsibilities. Performs all job responsibilities in compliance with applicable regulations and standard operating procedures. 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. Lifting up to 20 pounds regularly Sits for long periods of time, > 75% of work time. Walking, bending, kneeling, and standing part of the time < 25% of work time. Follow written and verbal instructions. 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. Interacts with all Visual Inspection staff on a daily basis. Communicates and Collaborates with Quality, Materials Management departments and other departments as needed. 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. Previous employment within and FDA/USDA, GMP environment is desired. High school diploma or equivalent required Basic computer skills are required. Basic verbal and written skills Able to understand and follow instructions. Ability to read, understand, follow, and comply with technical and written documents (SOPs) written in English. 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 PPE for all GMP areas for an entire shift (Includes non-latex gloves, hair\beard covers and lab coats) Detail oriented, and self-motivated. Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in all work activities and in the delivery of PCI products and services. Honesty, integrity, respect and courtesy with leadership and peers Openly receives and implements feedback, resilient, able to move past mistakes; applies learning #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future 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.

Requirements

Must-haves

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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.
Repetitive handling of sterile filled containers while primarily in a seated position, swirling and inverting containers and extending arm out in front of light source in order to identify product defects.
Records production quantities and other applicable information with adherence to Good Documentation Practices
Applies a moderate level of math skills to include piece counting, time calculations, and product reconciliation.
Following written procedures and documents results in a neat and accurate manner according to GMP standards and other regulations.
Performs daily cleaning of visual inspection and packaging areas in accordance with established procedures.
Identifies and communicates product quality issues.
Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines.
Effectively communicates both verbally and in writing with all levels.
Maintains a high level of integrity while balancing all job responsibilities.
Performs all job responsibilities in compliance with applicable regulations and standard operating procedures.
Lifting up to 20 pounds regularly
Sits for long periods of time, > 75% of work time.
Walking, bending, kneeling, and standing part of the time < 25% of work time.
Follow written and verbal instructions.
Interacts with all Visual Inspection staff on a daily basis.
Communicates and Collaborates with Quality, Materials Management departments and other departments as needed.
Previous employment within and FDA/USDA, GMP environment is desired.
High school diploma or equivalent required
Basic computer skills are required.
Basic verbal and written skills
Able to understand and follow instructions.
Ability to read, understand, follow, and comply with technical and written documents (SOPs) written in English.

Nice-to-haves

None flagged.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long

Benefits

Benefits detected in the listing.

Vision