QA Specialist II, Cell Therapy - Contract - Philadelphia, PA
Proclinical is seeking a highly motivated QA Specialist II to join the Quality Operations team for a night shift role. This position involves ensuring compliance with cGMP regulations and internal policies, working closely with manufacturing personnel to maintain high standards of work.
Shifts:
- Wednesday to Saturday 7pm - 6am (2 roles open)
- Sunday to Wednesday 7pm - 6am (1 role open)
Primary Responsibilities:
The successful candidate will act as a key point of contact between manufacturing and Quality teams, ensuring informed decision-making and compliance with release processes and procedures.
Skills & Requirements:
- A bachelor's degree in science, Engineering, or a related technical discipline or equivalent industry experience.
- At least: 3+ years' experience in a regulated industry.
- Working knowledge of cGMP regulations.
- Prior experience and ability to work in an aseptic processing environment.
- Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
- Attention to detail.
- Knowledge of QMS systems is a plus.
The QA Specialist II, Cell Therapy's responsibilities will be:
- Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
- Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
- Disposition incoming raw materials
- Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements
- Maintain and report on Quality Metrics.
- Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. Maintain and report on Quality Metrics.
- Other tasks as assigned.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator.
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Ability to lift 20 lbs.
Mental:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
Work Environment:
- Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
- This position will work in both an office and a manufacturing lab setting.
- When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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