PLS GMP Data Reviewer (Pharma)

Pace® Analytical Services•Oakdale, MN

2d•$55,000 - $65,000•Onsite

About The Position

Responsible for providing advanced oversight of the analysis and administration of various quality policies, programs, and practices in accordance with current Good Manufacturing Practices (cGMP); provides feedback, direction and guidance to employees and management, using advanced professional and technical knowledge of quality or related equipment, testing, and procedures. Pace® Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization. Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

Requirements

Bachelor's degree in chemistry, operations, or a closely related field; AND two to four (2-4) years of quality experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience.
Intermediate to complex principles, practices, and techniques of quality.
Various understanding of the administration and oversight of quality programs, policies, and procedures.
Intermediate to complex methods to resolve quality problems, questions, and concerns.
Various understanding of applicable quality laws, codes, and regulations.
Understanding of various testing tools, equipment, and calibration.
Computer applications and systems related to the work.
Principles and practices to serving as an effective project team member.
Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
Correct business English, including spelling, grammar, and punctuation.
Performing intermediate to complex professional-level quality duties in a variety of assigned areas.
Overseeing and administering comprehensive and varied quality functions.
Training others in policies and procedures related to the work.
Serving as a team member and the development and management of projects.
Operating in a both a team and individual contributor environment.
Interpreting, applying, and explaining applicable laws, codes, and regulations.
Preparing intermediate to complex functionals reports, correspondence, and other written materials.
Using initiative and independent judgment within established department guidelines.
Using tact, discretion, and prudence in working with those contacted in the course of the work.
Performing effective oral presentations to large and small groups across functional peers and the department.
Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

Responsibilities

Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information. This includes, but is not limited to manufacturing batch records, technical records, pertinent laboratory or quality control data, standard operating procedures (SOPs), quality exceptions, logbooks, tracking systems and LIMS data/reports. Data and records may be in the form of electronic or paper records or laboratory notebooks.
Provides intermediate to complex analysis, interpretation and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices; involves varied operations and leading implementation and change.
Provides various research, feedback, and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required.
Analyzes and reviews intermediate to complex operations, results, feedback, and related quality information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.
Ensures the accuracy of various tests, equipment, actions, procedures and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.
Assists with developing or participating in quality or cross-functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management.
Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed.
Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.