Quality Assurance Specialist

SUMMARY: The Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release, support shipments and facilitating timely release of production lots for Tecelra and other clinical products. The successful candidate will work closely with other Quality groups, Quality Control and Manufacturing to identify strategies, tactics and objectives for product quality and GMP compliance.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• Conduct record review of executed batch records and associated batch file documentation to ensure timely disposition of patient lots.
• Perform disposition of lentiviral vector and finished drug product batches.
• Liaise with external CMO and contract Qualified Persons in support of manufacture and release of lentiviral vector or T-cell drug product for US, EU and UK use
• Performs line/room clearance to support manufacturing activities in aseptic suites
• Print, issue and reconcile production labels, QC labels and final product labels
• Inspect, review and release raw materials and consumables for GMP use
• Provide QA oversight of incoming and outgoing shipments of apheresis, lentiviral vector, or finished T-cell drug product
• Manage Deviation, CAPA or Change Control records related to Quality Assurance operations
• Create or revise Quality SOPs
• Occasional weekend work required
• Other responsibilities as required

QUALIFICATIONS:

• Bachelor's Degree in a scientific discipline.
• Minimum of 2 years in a biopharmaceutical or biological manufacturing environment with exposure to Quality GMP operations.
• Familiarity with review and approval of batch records
• Knowledge of aseptic processing and aseptic gowning techniques
• Ability to qualify in aseptic gowning; prior experience in aseptic gowning preferred
• Knowledge of GMP, ICH and FDA/EMA regulations
• Knowledge of Quality Systems, such as Change Control, Investigations, and CAPA

COMPETENCIES:

• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Computer Skills - Skilled with computers; Uses technology to enhance job performance.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things
• Innovation - Meets challenges with resourcefulness; Generates suggestions for improving work.
• Motivation - Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Supports affirmative action and respects diversity.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Strategic Thinking - Develops strategies to achieve organizational goals; Adapts strategy to changing conditions.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Frequently required to stand for extended periods
• Frequently required to walk
• Frequently required to sit
• Frequently required to talk or hear
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

• The noise level in the work environment usually is quiet