Senior Q+A Specialist

PLEASE NOTE: This position is located at our Client's site in Pennsville, NJ!

Our Client is a preferred production and service partner for the worldwide pharmaceutical industry, which draws on a 140-year tradition that brings together chemicals and pharmaceuticals expertise under one roof.
 

Our Client develops and produces active pharmaceutical ingredients, intermediates and complex dosage forms. Every day, around 2,300 committed employees in Switzerland, Germany, France, Malta, the USA and China work on innovative, integrated solutions for their clients.

At its locations around the world, Our Client offers employees exciting career opportunities in international settings. They cultivate multidisciplinary cooperation and encourages their staff to actively shape and influence their careers. This approach, coupled with their dynamic working environment, makes Our Client an attractive employer.

Key tasks:

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:

• Reviews and approves executed production records, production investigations, Master Production Records, COAs and DMFs
• Reviews lab sample results and manufacturing records relative to qualification and validation activities.
• Conducts, writes, and reviews quality related investigations
• Responsible for cGMP compliance of assigned manufacturing operations / areas and conducts cGMP inspections
• Completes pre-campaign action items as assigned.
• Responsible for the conditional / final release of materials
• Reviews finished product labels.
• Prepares and reviews product trees
• Writes and reviews Product Validation / Qualification / Assessments documents, Equipment Qualifications / Assessments documents and Computerized Systems Validations / Assessments documents
• Reviews, evaluate and approves minor equipment changes
• Conducts environmental monitoring
• Maintains QA databases for products / equipment

Education and Experience:

• BA/BS degree in microbiology (preferred), biology, chemistry, or engineering and 3-5 years of experience in auditing in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.BA/BS degree in microbiology is preferred
• Thorough knowledge of cGMP is required

Other Requirements:

• Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Our Cleints Code of Conduct
• Adheres to all applicable SHE and CGMP regulations
• Must have excellent communication skills
• Must be conscientious and detail-oriented
• Must have excellent computer skills (MS Office, WinLIMS, SAP)
• Must be a team player
• Must be able to self-manage daily work and set priorities
• Must be able to manage projects and prioritize appropriately

JANAS Staffing was founded under the premise of honesty as well as taking care of both the customer and the applicant. We consider ourselves matchmakers rather than recruiters as we "match" candidates and employers with their ideal job/candidate. We pay close attention to our Client's company, particularly the culture, as we feel that this is a deciding factor as to whether or not someone will continue in a role or move on soon after they accept the offer. We also pay close attention to our candidate's needs and make sure that at every step of the process, they are happy with their decision to make a change.

We specialize in high-volume recruiting as well as the following:
- Financial Services
- Information Technology
- Technical
- Engineering
- Warehouse/General Labor
- Bio-Technical
- Administrative

If you qualify for one of our open roles, apply today!