Pace Analytical Services

QA SPECIALIST II (PHARMA BIOTECH)

SUMMARY

We are actively seeking a candidate to support our Quality Assurance (QA) team. The ideal candidate is one who thrives working in a highly dynamic, fast-paced, team-oriented environment, sharing the common goal of providing our clients with accurate information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical, biologics, and medical device products.

The QA Specialist is directly responsible for independently auditing analytical projects with minimal guidance for adherence to procedures and regulations related to pharmaceuticals. This includes data package review, some aspects of document control, GLP, walkthroughs of the laboratories, archiving projects, QA oversight of electronic data processing, following cGMPs to ensure compliance to applicable guidelines, administrative tasks, method approvals, protocol approvals, report approvals, internal audits, data auditing, consulting with internal clients to provide guidance and direction, as well as other tasks identified in PLS SOPs. The QA Specialist will collaborate with the Raleigh, NC QA staff on a routine basis to accomplish harmonization. The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of initiative, a desire to collaborate with all departments, and an interest in continuing to acquire new knowledge and skills.

ESSENTIAL FUNCTIONS

• Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information. This includes, but is not limited to 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, worksheets, 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.
• 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.

QUALIFICATIONS

Education and Experience

• Bachelor's degree in chemistry or a closely related field.
• Three to five (3-5) years of quality experience, including experience with complex programs; OR an equivalent combination of education, training, and experience.

Required Knowledge and Skills

Required Knowledge

• 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 serve 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.

Required Skills

• 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.
• Auditing intermediate to complex 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.
• Addressing work issues proactively at the individual level.
• Recognizing unmet needs within the department.
• Collaborating with peers and demonstrate leadership capabilities.
• Utilizing a strategy that is focused on personal time management and efficiency.
• Identifying aberrant data and potential quality/compliance concerns and escalating them to management when needed.
• Receiving instruction, guidance, and direction from others
• Working effectively under pressure to meet deadlines.