Quality Assurance Specialist

Title: Quality Assurance Specialist
Location: Quakertown, PA
Industry: Pharmaceutical Manufacturing
Pay: $70K/yr.
Employment Type: Permanent

Overview:
Join a cutting-edge pharmaceutical manufacturer that s been trusted by top innovators for over 30 years. Be part of a highly specialized team known across North America for enhancing solubility and bioavailability through advanced particle size control. With a 100,000+ sq. ft. facility and custom-engineered technology, this is your chance to work where science meets scalability and where your work directly supports drug development from discovery to commercial launch.

The Quality Assurance Specialist is critical to the Company s success in providing a quality service to our customers by ensuring compliance to current regulations along with batch record reviews to support product release within a timely fashion. This position carries out their duties by assisting our organization to support our Quality Systems to ensure that current cGMPs are adhered to through attention to details during document reviews. This position reports to the Quality Manager and participates in cross-functional duties within the Quality Department which includes, but not limited to, batch issuance and postproduction reviews in support of batch record and product release to production and product release to the customer postproduction.

Job Responsibilities

• Attentive to detail during documentation review to ensure cGMPs and SOPs are adhered to and non-conformances are reported.
• Batch record assembly.
• Batch record issuance to production.
• Postproduction batch record review.
• Review and release of documents, components and raw materials to support production activities and product release.
• Inspection and release of labels, consumables, product and equipment after cleaning. Assist with quality related investigations.
• Provide assistance to QA management for updating of procedures and forms.
• Maintain accurate records and documentation.
• Perform other business critical duties, when necessary, as determined by management.
• Work additional hours as needed to support the business to include end of month activities. (No more than 8 hours per week)

Education:

• Associates degree in scientific field
• 0-4 years of experience
• Computer Software skills, record keeping, detail orientated and thorough
• Experience with ERP systems, Master Control a plus. May assist to report on quality metrics.
• Basic understanding of cGMP regulations and general knowledge of manufacturing processes.
• Shows initiative and is skilled in prioritizing workload in a busy manufacturing environment.

SRG4 Life Sciences delivers flexible staffing solutions nationwide, specializing in pharmaceutical, CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical, laboratory, and consumer product sectors. We provide contract, contract-to-hire, and direct hire placements across a wide range of critical roles including Scientists, Formulators, Engineers, QA/Regulatory Affairs, Microbiologists, Manufacturing Technicians, Supply Chain/Procurement Specialists, Project Managers, and Business Development professionals. SRG4 Life Sciences operates on a relationship-driven model partnering closely with clients to understand not only the role, but the company s culture, goals, and vision. Our mission is to match purpose-driven professionals with organizations committed to advancing human health, building long-term partnerships that drive innovation, quality, and performance.

EOE/ADA
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