Job Summary

Prolacta Bioscience is seeking a QC Senior Compliance Specialist, fully competent to serve as a senior level Subject Matter Expert (SME), technical resource and contributor in one or more specialized functions. The QC Sr. Compliance Specialist is required to lead and support the development and implementation of compliance programs for the organization and the monitoring of business activities for compliance with applicable rules and regulations (i.e. support quality and regulatory compliance for testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling). Additionally, the QC Sr. Compliance Specialist is required to lead simple to moderately complex, OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action), and contract laboratory investigations. This role is required to work closely with and support each of these systems as they relate to the testing performed for Prolacta. 

Primary Duties and Responsibilities

• In-depth understanding and adherence to the Quality System requirements established by Prolacta Bioscience

• Knowledgeable in all conventional aspects of field

• Demonstrates full understanding of routine laboratory procedures

• Demonstrates expert knowledge of project/process flow within discipline

• Applies extensive technical expertise and has knowledge of other related business disciplines/processes

• Identifies areas for continuous improvements and efficiencies in compliance and quality systems

• Independently evaluates, selects, and applies standard techniques and procedures

• Responsible for ensuring QC compliance with all Federal, State, local and company regulations, policies, and procedures related to EHS (Environment, Health and Safety) practices

• Identify gaps in corporate practices, policies, and procedures

• Identify emerging trends in laboratory compliance (i.e. FDA, ICH, compendial revisions and laboratory safety), corporate practices, policies, and procedures

• Facilitates the prioritization of work based on current regulatory environment, guides, and regulations

• Ensures operating manuals and procedural documents stay current when regulations change

• Leads and works closely with staff on OOS, NC, LIR, OR, CA and/or CAPA investigations, reports, and root cause analysis for all testing that occurs within the Prolacta and contract laboratory for GMP production, studies, and investigations

• Provides subject matter expertise for the evaluation and conclusion of laboratory investigations

• Utilizes significant knowledge of raw materials and finished goods testing in preparing conclusions and recommendations

• Work closely with Quality Assurance (QA) to implement systems to support and ensure inspection readiness in the laboratory for QA Walk-Throughs

• Work closely with the QA Training Specialist as needed to provide necessary technical support for the training program pertaining to the QC department

• Provide the support required to generate installation/operation/performance qualifications for QC analytical instrumentation

• Ensure QC instruments and equipment are calibrated and maintained

• Operates, maintains, and troubleshoots advanced analysis equipment

• Support the development and execution of validation studies and research projects

• Works on complex projects requiring evaluation of materials testing

• Maintains a safe and clean laboratory

• Disposes of hazardous/biohazardous wastes according to Prolacta established procedures

• Performs environmental monitoring (gowning required)

• Write and/or revise Prolacta’s complex Standard Operating Procedures (SOPs)

• Provides leadership, guidance, and training to junior colleagues on a regular basis

Job Requirements and Qualifications

• Bachelor’s degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, or related discipline
  (OR)

• At least 5 years of directly applicable experience; hands-on experience in manufacturing, operations, or pilot lab/scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry high desired

Other Knowledge, Skills and Abilities

• Business Acumen – Demonstrates advanced knowledge of Prolacta products, technical operations, strategy, industry trends, and Prolacta SOPs

• Collaboration

• Develops cross-functional partnerships and initiates new and productive internal/external alliances

• Communication – Regularly interacts with team members, management, contacts among functional areas, and other departments within the company

• Computer Skills – Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)

• Critical Thinking – Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems

• Customer Focus

• Ensures products meet client requirements

• Assesses customer needs and develops options to meet those needs

• Presents options and recommendations to management/customer(s)

• Efficient – Performs highly detailed work on multiple, concurrent tasks, while working under strict deadlines

• Good Judgment – Work performed without appreciable direction

• Guidance

• Provides constructive feedback to help others develop

• Builds consensus, encourages two-way feedback, and acknowledges contributions of others

• Encourages work group members to pursue excellence through diverse perspectives

• Problem Solving

• References and researches established practices, standards and/or policies to provide solutions to a variety of difficult problems

• Effectively challenges current processes and recommends improved approaches; solutions are thorough, practicable, and consistent with organization objectives

• Teamwork

• Ability to work independently and as part of a team

• Facilitates cooperative behavior among departments

• Written/Oral Skills – Regularly required to demonstrate strong written communication and oral skills

Work Environment (Location, Travel, Shift, On-Call, etc.)

• This position requires working in a laboratory/office setting for an 8 hour shift 

• Required to support the QC Lab at both the City of Industry and Duarte locations

• Up to 10% car travel between locations may be required