QA Associate II

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: The QA Associate II is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements. The Associate II leads projects, trains junior staff, coordinates daily activities, independently provides quality oversight and support on the floor during manufacturing operations, ensures documents are reviewed for completeness and accuracy. Promotes cGMP environment and follows SOP. ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED: Manages the review of records and associated data in support of GMP operations activities (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records) Assists in the review and approval of internal production batch records and associated data for product disposition. Performs the review and data entry for calibration, preventative maintenance and validation activities. Supports the Red Tag and Asset Management Process. Executes QARM responsibilities. Designated subject matter expert during AQL inspection Processes Technical Quality documentation initiation, revisions, and deletions. Assists in the review and approval of executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product batches Performs real time, on -the-floor documentation review during commercial packaging and labeling activities. Sterile gown qualified to support cGMP activities in sterile suites. Oversees scheduled facility walk-throughs and material destruction. Regular and reliable attendance on a full time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures. Embodies PCI Pharma’s cultural values and aligns daily actions with department goals and company culture. EDUCATION AND EXPERIENCE: Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent. Minimum of two to four (2-4) years of experience in documentation, QA, or equivalent. Knowledge of cGMP regulations and good documentation practices preferred. Ability to distinguish one or several chromatic colors, independent of the capacity for distinguishing light and shade. Demonstrated ability to follow detailed directions in a laboratory environment. VISUAL DEMANDS: This position includes essential tasks that experience and applicable standards show require 20/20 vision (natural or corrected) in order to perform the position in question. This position also requires the ability to see and differentiate among colors. The hiring rate for this position is $24.08 - 27.09 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-AC1 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.