The QA Oversight Associate provides support to all functions associated with manufacturing and quality control operations via daily on-the-floor support. The oversight includes evaluation and review of ongoing Manufacturing and Quality Control Operations, and management of all Quality functions related to facility, systems, and manufacturing support. Other areas include (but are not limited to) Metrology, Engineering, Maintenance, and Information Systems (IS). Essential responsibilities include but are not limited to:
Ensure that all applicable US and European regulatory requirements are being met within the procedures and practices of the Manufacturing and Quality Control units.
Conduct daily “audits” of the Manufacturing and QC facilities to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP).
Provide necessary daily, weekly and monthly summaries and reviews for on the floor observations, provide responses to observations and ensure that all corrective action measures are completed as described and within the time-frame given in the response.
Recognize potential problems and/or document problems encountered, following up with department supervisors to assure corrective actions are taken to resolve any deficiencies in product quality or manufacturing systems and procedures.
Ensure that investigations related to deviations in facility or support systems are complete and adequate.
Position requires the ability to solve complex problems independently and within a team environment.
QA oversight of aseptic processing.
Assist in training of any new QA Oversight personnel.
Bachelors of Science Degree in a scientific discipline (or 4 years of technical manufacturing experience in lieu of degree) required.
Minimum of 3 years related experience and Pharmaceutical experience required.
FDA Regulated Industry required.
Proficiency in Microsoft Word, Excel and PowerPoint required.
Mechanical Aptitude desired.
In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with manufacture of sterile products, testing required on those products, and relationship of quality principles with manufacturing and testing required.
Excellent interpersonal skills required. Interaction with departments and inspectors/auditors from regulatory agencies and customer companies.
Must be able to work off shift hours and weekends.
Physical Requirements: 20/30 corrected vision, exposure to allergens, working in aseptic areas, prolonged standing and sitting. Minimum travel required.
1 opening on day shift:
Monday - Thursday 5am – 3:30pm
1 opening on night shift:
Tuesday – Friday 7:30pm – 6:00am
1 off shift (Friday – Monday/Nights):
Friday & Monday midnight – 8:30am
Saturday & Sunday 8:00pm – 8:30am
Please be sure to include availability when applying.
About Jubilant HollisterStier
Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids. Our facilities in North America provide specialized manufacturing for the pharmaceutical and biopharmaceutical industries. We provide a full-range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release.