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Senior Technical Associate, Quality Assurance TechOpsFerring Pharmaceuticals Inc. • Parsippany, New Jersey, United States
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Senior Technical Associate, Quality Assurance TechOps

Ferring Pharmaceuticals Inc.
  • US
    Parsippany, New Jersey, United States
  • US
    Parsippany, New Jersey, United States
Jetzt Bewerben

Über

Job Description Senior Technical Associate, Quality Assurance ensures compliance with cGMP regulations and internal quality standards. This role reviews and approves quality system documents (e.g., Change Controls, Investigations, CAPAs, protocols, and validation reports), supports audits, and helps develop SOPs aligned with regulatory expectations.
The position also analyzes quality metrics, contributes to management reviews, and drives continuous improvement through cross‑functional collaboration. Additionally, it mentors QA staff and oversees task delegation to maintain high standards of quality and compliance.
Responsibilities
Quality review and approval of Change Controls, Investigations, Procedures, and CAPAs.
Review and approve protocols, reports, and other commissioning/ validation/ technical reports.
Assist with internal and external cGMP audits.
Takes the lead in preparing and / or reviewing SOPs related to quality systems. In addition, final QA review of SOPs related to Production, Engineering, Facilities / Maintenance, Validation, Supply Chain, and QC.
Prepare, review, and approve Test Methods and specifications.
Prepare statistical data for monthly, quarterly and annual Quality Review Metrics. Assist in preparing Quality Review Board Presentations to Senior Management.
Act as a QA representative for cross functional process improvement projects and lead quality continuous improvement initiatives.
Assign tasks to QA Technical Associates as needed and provide mentoring and coaching to ensure product quality and compliance with applicable regulations and procedures.
Performs other duties as assigned by Quality management.
Requirements
Bachelor of Science degree in Natural Sciences, and / or Engineering from an accredited college/university.
Seven years (7) experience in Quality Assurance supporting GMP production, cell therapy, or similar within the pharmaceutical, biologics or other similar industries.
Strong understanding and experience (5 years) with Aseptic Techniques, cell manufacture processes and technologies preferred.
Experience with qualification and validation principles (i.e. Process, Cleaning, Computer Validation, Equipment / Utilities Qualification, Commissioning, and Method Validation).
Demonstrated ability to interpret cGMP, 21CFR 210 and 211, other applicable regulations, standards and guidance.
Knowledge of applicable regulatory frameworks and requirements for cell and gene therapy, such as GMP, ISO, or medical device development.
Knowledge of standard industry documentation, training, and investigations practices is required.
Advanced understanding of quality systems within the manufacturing pharmaceutical/biopharmaceutical or medical device industries.
Strong verbal and written communication with ability to communicate complex ideas and concepts.
Independent, detail oriented, self‑starter.
Ability to manage multiple tasks/projects.
Ability to effectively negotiate and influence key partners and suppliers to meet requirements and commitments.
Drive for Results.
Excellent problem‑solver with the ability to work independently.
Proficient in Microsoft Word, Excel, Access, PowerPoint and Adobe Acrobat.
Physical Job Requirements
Ability to occasionally stand, walk, and move between office, laboratory, and manufacturing areas
Capability to wear required personal protective equipment (PPE) when entering production or lab environments
Ability to lift and carry light materials (typically up to 10lbs), such as files, binders, or a laptop
Our Compensation and Benefits At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $100,000 to $125,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non‑discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus – payouts are based on individual and company performance. Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long‑term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full‑time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Role will be in Parsippany, NJ.
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  • Parsippany, New Jersey, United States

Sprachkenntnisse

  • English
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