Elba Laboratories is a commercial CMO based in Troy, MI with specialized expertise in product development, commercial manufacturing and packaging of topical OTC, cosmetic skin care and oral liquid products. Elba is an FDA regulated facility practicing cGMP, seeking a Quality Assurance Specialist focusing on Documentation Control to join our team.
Summary: Plans, conducts, and supervises activities concerned with the quality assurance of pharmaceutical and cosmetic processes, materials, and products by performing the following duties.
Key Responsibilities include but are not limited to:
- Supervise quality assurance staff.
- Quality oversight of the production floor operations.
- Creates controlled documentation (i.e. SOPs, fill documents, batch records, etc.) using a document control system.
- Assists in filing, tracking, trending, retrieval, and retention of GMP documentation.
- Assist with ensuring that master labels and proofs are current.
- Assist with training new employees on Good Manufacturing Practices.
- Assist with internal audits of Elba systems and documents to ensure compliance to applicable Elba policies and SOPs.
- Assists with CAPA, non-conformance, change controls, customer complaints, and other investigations, as assigned.
- Utilizes quality tools such as fishbone diagrams, fault tree analysis and others to drive root cause analysis for non-conformances.
- Responsible for inspection of compounding department; activities include verifying that weights are consistent with the formulas, raw materials used are consistent with formulas, raw materials are within expiry, and raw material are appropriately tagged with the receiving number.
- Responsible for inspection of production lines, including verifying lot number, expiration dates, and proper label usage.
- Performs monthly inspection of raw material warehouse and resolution of issues.
- Participates in the final release process for finished package goods.
- Performs the inspection and approval of packing components, maintenance of specifications and component samples.
- Responsible for the maintenance of label inventory.
- Responsible for expiration dating log of finished products.
- Responsible for maintaining and monitoring temperature and humidity chart recorders.
- Responsible for maintaining quarantine and rejection areas.
- Release of equipment (post cleaning).
- Ensure cGMPs are being followed by production personnel.
- Ensure all production paperwork is being filled out and signed by the appropriate personnel during the manufacturing process.
- Ensure that hygienic practices are being carried out during the staging, filling and packaging of finished goods.
- Ensure that only approved material is being used in the manufacturing and packaging processes.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor's degree (B. A.) from four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, cosmetic, biologic or medical device industries in a Quality Assurance. Prior management experience desired.
Ability to read batch records, SOPs, and other documentation critical to daily operations. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Functional in the use of a computer including software such as Microsoft Word, Excel and Access.
Certificates and Licenses:
No certifications needed
Directly supervises employees in the Quality Assurance production area. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include Close vision, Distance vision and Peripheral vision. While performing the duties of this job, the employee is frequently required to stand; walk; sit and talk or hear. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
Disclaimer: This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of this position. It is not intended to limit, or in any way to modify the right of any supervisor to assign, direct, or reassign duties and responsibilities to this job at any time. The use of a particular illustration shall not be used to exclude non-listed duties of similar kind or level of difficulty.
An Equal Opportunity/Affirmative Action Employer
ELBA Laboratories is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at ELBA Laboratories are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. ELBA Laboratories will not tolerate discrimination or harassment based on any of these characteristics.