Manufacturing Quality Assurance (MQA) Specialist Mon-Fri 8-5 at SCA Pharma

Description

Company Description

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The Manufacturing Quality Assurance (MQA) Specialist is responsible for oversight of all operational and pharmacy areas ensuring adherence to cGMP and Standard Operating Procedures, Document Control, as well as timely review and release of batch records. This role will require close collaboration with operations personnel of all levels.

Essential functions: 

Manufacturing Quality Assurance and Efficiency (MQAE):

• Oversees all operational and pharmacy areas ensuring adherence to cGMP and Standard Operating Procedures
• Perform assessments during operations activities, both within the cleanroom and outside of the cleanroom, to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Assist with the improvement and development of SCA’s SOPs, Batch Records, Forms, etc. as well as evaluate to ensure compliance with cGMP and cGDP
• Performs Document Control Functions within document retain room and within MasterControl

Batch Record Review Release:

• Review executed batch records 
• Proactively perform follow up on outstanding issues to ensure timely batch disposition
• Review of QC Data for approval and releasing of batch records 
• Effectively disposition a batch ensuring compliance with regulatory and internal requirements
• Generate and approve SCA Certificate of Compliance

Document Control (if applicable):

• Support maintaining and organizing documents on site
• Support electronic document control within quality management system
• Coordinate with our document storage and shredding vendor to maintain our documents off-site
• Maintain spreadsheets to track logbooks as well as create logbooks
• Support document requests during audits

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 3 years of quality experience in pharmaceutical, medical device or other related industries preferred

Desired Knowledge, Skills, and Abilities:

• Proficient in the Microsoft Office Suite (Excel, Word, Outlook)
• Ability to maintain gowning certification, enabling access to the cleanroom.
• Have effective communication (both written and verbal).
• Demonstrate strong technical writing skills, decision making abilities and critical thinking.
• Be able to manage multiple investigations and adhere to on time closure deadlines concurrently.
• Possess knowledge of aseptic technique.

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.

Requirements

Required Qualifications & Experience:

• Bachelor’s degree in life sciences, engineering, or related discipline.
• 3 years of quality experience in pharmaceutical, medical device or other related industries preferred

Desired Knowledge, Skills, and Abilities:

• Proficient in the Microsoft Office Suite (Excel, Word, Outlook)
• Ability to maintain gowning certification, enabling access to the cleanroom.
• Have effective communication (both written and verbal).
• Demonstrate strong technical writing skills, decision making abilities and critical thinking.
• Be able to manage multiple investigations and adhere to on time closure deadlines concurrently.
• Possess knowledge of aseptic technique.

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.