QA Compliance Specialist - Apex Systems

Job#: 2057616

Job Description:

Seeking a QA Specialist to join a Pharmaceutical company in the Milwaukee, WI area.
SUMMARY:
The Quality Assurance (QA) Compliance Specialist I is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations. This position’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMPs and internal procedures/policies are maintained, and b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:

• Maintain environmental monitoring database and compile trend reports
• Maintain Quality databases including Archival and scanning of cGMP documents and records, Departures, media fill programs, and training files
• Perform real-time batch record review to ensure the executed record may be delivered to Quality Assurance, 100% completed and ready for review
• Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
• Solicit feedback from Manufacturing for operational improvement. Liaison with Process Engineering to ensure that Manufacturing feedback is incorporated, where appropriate, into the process design
• Author or revise SOPs
• Perform manufacturing area and labeling clearances as well as inspection of material
• Review and approve CAPAs, Deviations, Change Controls, Equipment Excursion Reports
• Assist in performing investigations
• Perform internal audits and weekly walkthroughs
• Perform QA visual inspection activities associated with clinical and commercial drug product
• With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
• Assist in developing and delivering training
• Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
• Develop and/or maintain Quality System metrics for management review

• Associates’ degree in related field required

• Bachelors’ degree in life science field
• 3-5 years’ experience in a cGMP FDA-regulated industry

• Strong familiarity with the regulatory requirements of 21CFR210 and 211 or 820
• Excellent written/oral communication skills
• Focused self-starter with attention to details; team-oriented but able to work independently and proactively, and ability to multi-task
• Strong problem solving and organizational skills
• Experience working in a cleanroom with a thorough understanding of cleanroom personnel and material flows a must

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.