Quality Assurance Associate

Lyne Laboratories is a privately held, well-established company with a successful history of manufacturing liquid, semi-solid and powder formulations of both prescription and OTC products.

The ideal candidate must be highly motivated individual with an interest in pharmaceuticals to join its Quality Assurance team as a Quality Assurance (QA) Associate. The QA Associate reports directly to the Quality Assurance Manager and will work alongside a team of like-minded quality personnel to ensure the quality and integrity of Lyne’s manufacturing, filling, and packaging operations on a day-to-day basis. QA Associate is to provide internal support to Lyne Laboratories, Inc. personnel with day-to-day operations as it relates to quality system programs, which may include, but is not limited to documentation filing and archival, record/data review, and Customer Complaints. In addition, The QA Associate will also have responsibility for the compilation, review, approval, and release of batch records, components, and raw materials, as required.

Responsibilities:

• Compiling, reviewing, and approving batch records for production activities as well as for release of product from the Lyne Laboratories, Inc. site for distribution.
• Review, approval, and release of raw materials and components.
• Compiling and logging Environmental Monitoring (EM), Quality Control (QC), and Annual Product Review (APR) data.
• Stability Profiling of collected QC data.
• Generation of Certificates of Analysis, Conformance, and Manufacturing as part of Batch Records.
• Collaborate with QA Inspectors to monitor and support daily activities, as needed.
• Document/Record filing and archival.
• Batch Record generation.
• Supplier Auditing.
• Participation in the Quality Management System (QMS) to ensure the quality and integrity of company records and activities.

Qualifications

The ideal candidate must possess the following qualifications for consideration for the QA Associate position:

• A minimum of a Bachelor of Science (B.S.) degree, or equivalent work experience required.
• A minimum of one (1) year of work experience in a pharmaceutical, CGMP, or healthcare-related field required, preferably in a quality role.
• Basic understanding and/or familiarity with Current Good Manufacturing Practices (CGMPs) and Current Good Documentation Practices (CGDPs) concepts, or ability to learn of said concepts.
• Basic knowledge, familiarity, or ability to learn US Food and Drug Administration (FDA) Regulations.
• Computer/IT skills in MS Word and Excel required.
• Interpersonal verbal and written communications skills; analytical skills.
• Ability to balance priorities and pivot focus, when needed, based on site/customer needs and quality risk to product/personnel.
• Ability to read and understand basic documentation, which may include but is not limited to: standard operating procedures (SOPs), forms, protocols, and other document records

Required Skills

• Excellent verbal and written communication
• Strong Analytical Skills
• Strong attention to detail Must be detailed oriented, demonstrates accuracy and thoroughness.
• Good problem solver
• Multitask – work on multiple projects simultaneously with sense of urgency.
• Strong organizational skills, prioritizes and plans work activities and uses time efficiently.
• Works well in a team environment but can work independently.

Job Type: Full-time

Pay: From $45,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Work Location: In person