Job Opening - QC Sr. Lab Manager
G & W Labs - South Plainfield, NJ

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Job Opening - QC Sr. Lab Manager

Basic Function and Responsibility:

Oversee the Quality Control Analytical Laboratory and other units in Quality Control, namely, stability testing unit, microbiology unit and calibration/standardization unit to ensure compliance with cGMP's, FDA, and ICH guidelines. Responsible for all aspects of the department from personnel to scheduling of activities to budget and expense control. Initiate new programs to meet company and compliance objectives.

Work Performed:

Direct QC activities including the analysis and release of finished products, in-process, raw materials, stability samples and packing components

Develop and implement Quality Control at all critical stages of the production of pharmaceutical products in keeping with the cGMP regulations

Implement various tests, methods, controls, procedures as supplied for each product and raw material by ARMD and vendors. Collaborate with ARMD or outside laboratories to resolve any analytical testing problems, recommend appropriate changes if required

Oversee stability testing unit through the Stability Supervisor ensuring compliance with stability SOP's, cGMP and ICH guidelines

Oversee microbiology testing unit through Microbiology Unit Manager ensuring compliance with microbiology SOP's and cGMP regulation

Oversee calibration/standardization unit through the Metrologist/Calibration Specialist ensuring that qualifications of laboratory equipment, records of calibrations and maintenance are in compliance with SOP's and cGMP regulation

Select, train, supervise laboratory professional personnel in the performance of the testing procedures (analytical or microbiological) required to meet regulatory and scientific standards for pharmaceutical products. Review, audit, approve and/or critique test results and records of laboratory personnel

Review all major validation protocols and validation testing data. Evaluate and recommend to - Vice President of QA/RA

Work closely with production department. Conduct analytical and microbiological investigations for troubleshooting of production problems

Work closely with QA/QC/RA. Provide necessary documents for ANDA submissions. Prepare stability annual reports of all G&W products for the Regulatory Affairs to submit to the FDA

Issue and approve reports of product analysis activities, costs or other as required. Maintain all required records

Update laboratory equipment and facility to ensure that the QC activities are keeping in line with the current technological and safety standards

Audit outside testing laboratories or manufacturing sites, if required

Aspects of Performance:

Maintains confidentiality

Possesses sound analytical problem-solving and documentation skills

Demonstrates ability to prioritize conflicting demands

Executes assigned tasks within established schedules

Writes and speaks clearly and concisely

Develops and maintains expertise through continuing professional education and training

Complies with Company policies, procedures, rules and regulations

Qualifications:

A strong background in analytical chemistry/quality control. Possess excellent communication skills.

Education:

Masters or Ph. D. degree in chemistry or related field preferred.

Experience:

15 years for BS degree10+ years for MS degree and 8+ years for Ph. D. degree in Pharmaceutical industry. At least 10 years experience of managing a quality control laboratory.

Please provide desired salary in order to be considered for position.

G & W Labs - 19 months ago - save job - block