|
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 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 basic duties and responsibilities include the following, but other duties may be assigned.
Repetitive handling of sterile filled containers whileprimarilyinaseated position, swirling and inverting containers and extending arm out in front of light sourcein order toidentify product defects. Records production quantities and otherapplicableinformationwith adherence to Good Documentation Practices Appliesamoderate level of math skills toincludepiece counting, time calculations, and productreconciliation. Followingwritten procedures anddocumentsresults in a neat and accurate manner according to GMP standards and otherregulations. Performs daily cleaning ofvisual inspection andpackaging areasin accordance withestablishedprocedures. Identifiesand communicatesproductqualityissues. Maintains attention to detail and quality while completing multiple or repetitive tasks and meetingproducttimelines. Effectively communicates both verbally and in writing with alllevels. Maintainsa high levelof integrity while balancing alljobresponsibilities. Performs all job responsibilities in compliance with applicable regulationsandstandard operating procedures.
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. Required:
Previousemploymentwithin andFDA/USDA, GMPenvironmentisdesired. High school diploma or equivalentrequired Basic computer skillsarerequired. Basic verbal and written skills Able to understand and followinstructions. Ability to read, understand,follow,andcomply withtechnical and written documents (SOPs) written inEnglish. Must be able tomaintainvisual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multipleproducts. 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, andself-motivated. Commitsto conductingPCIbusiness according to the highest legal and ethical standards, and to continually pursue excellence inall work activities and in thedelivery ofPCIproducts andservices. Honesty, integrity, respect and courtesy with leadership and peers Openly receives and implements feedback, resilient, able to move past mistakes; applies learning
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.
|