QC Chemistry Supervisor

Pine Pharmaceuticals•Town of Tonawanda, NY

8d•$65,000 - $75,000

About The Position

The QC Chemistry Supervisor position is a hands-on position responsible for the oversight of the daily operations of the chemistry laboratory analyses and personnel performing chemical analysis and stability scheduling/testing. The supervisor will coordinate laboratory throughput and compliance activities, support development and validation activities and manage the stability program. Ensuring the maintenance of a cGLP laboratory and keeping up with regulatory requirements.

Requirements

A minimum of Bachelor’s degree in Biology, Chemistry, or other related science is required.
A minimum of 5 to 7 years of pharmaceutical laboratory experience is required.
Knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and ICH Guidelines.
Knowledge of statistical tools and trending data analysis
Experience with trending and maintaining product stability
Experienced in writing OOS/OOT and/or deviation investigations
Proficiency using LIMS, electronic Quality Management Systems
Experience with HPLC and chromatographic data software
Strong attention to detail with the ability to follow standard operating procedures.
Able to adapt and respond quickly in a fast-paced environment.
Ability to work independently.
Able to communicate in a professional manner and interact with management, clients, and vendors on routine basis.
Excellent organizational, verbal, and written communication skills.
Must be organized and flexible with an ability to handle multiple work assignments.
Good conflict resolution abilities to improve organizational productivity
Good interpersonal skills to identify and establish a purposeful team culture

Nice To Haves

1-3 years of Supervisory experience preferred.
Experience in Analytical Quality Control, method development, or a technical support function is desired.

Responsibilities

Execute, supervise, and review in-process, development, validation, release and stability testing on batches including, but not limited to, pH, Color and Clarity, Assay, etc.
Review/approval of release/stability specifications and stability protocols.
Assist in retrieval and compilation of quality metric data.
Point of contact when Quality Control Manager is unavailable.
Design and implementation of personnel schedule to meet production needs and support training requirements.
Author, review, and/or approve laboratory documents (i.e., protocols, reports, SOPs, test methods, technical documents, and risk assessments)
Assists in evaluation of new and existing analytical methods being transferred to or from the site.
Contributes, supports, and leads writing of OOS/OOT and nonconformance investigations.
Drives 5S and Lean projects.
Support internal and external audits of facility.
Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.
Support for junior analysts and chemists on proper equipment maintenance and troubleshooting failures.
Working as an effective team member to meet departmental objectives, sharing knowledge with team members and across the laboratory.
Promotes and maintains a safe, healthy working environment by instructing and enforcing compliance with established safe work practices and procedures.
May perform other duties as assigned.